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1. (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid
2. Alerlisin
3. Aller-tec
4. Cetalerg
5. Ceterifug
6. Ceti Tad
7. Ceti-puren
8. Cetiderm
9. Cetidura
10. Cetil Von Ct
11. Cetilich
12. Cetirigamma
13. Cetirizin Al
14. Cetirizin Azu
15. Cetirizin Basics
16. Cetirizine
17. Cetirizine Dihydrochloride
18. Cetirlan
19. Dihydrochloride, Cetirizine
20. P 071
21. P-071
22. P071
23. Reactine
24. Virlix
25. Voltric
26. Zetir
27. Zirtek
28. Zyrtec
1. Cetirizine Dihydrochloride
2. 83881-52-1
3. Zyrtec
4. Reactine
5. Cetirizine Dihcl
6. Cetrine
7. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride
8. Alerlisin
9. Cetirizine Hcl
10. Virlix
11. P 071
12. Zirtek
13. P-071
14. Zerviate
15. Cetirizine (dihydrochloride)
16. 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid;dihydrochloride
17. 83881-52-1 (hcl)
18. 64o047ktoa
19. Nsc-759102
20. Cetirigamma
21. Alercet
22. Alergex
23. Alertisin
24. Cetalerg
25. Ceterifug
26. Cetidura
27. Cetirlan
28. Cetriler
29. Cetzine
30. Formistin
31. Ressital
32. Salvalerg
33. Setiral
34. Stopaler
35. Voltric
36. Zyrzine
37. Alerid
38. Riztec
39. Virdos
40. Zirtin
41. Cezin
42. Ryzen
43. Zetir
44. Cetilich
45. Triz
46. Cetirizin Basics
47. Xero-sed
48. Ceti-puren
49. Cetil Von Ct
50. Cetirizin Azu
51. Children's Zyrtec
52. (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid Dihydrochloride
53. [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Dihydrochloride
54. Dsstox_cid_24268
55. Dsstox_rid_80138
56. Dsstox_gsid_44268
57. Ceti Tad
58. Alleroff
59. Allergy Relief
60. Apo-cetirizine
61. Zyrtec Allergy
62. Zyrtec Hives Relief
63. Cetirizine Hydrochloride [usan]
64. Ucb-p 071
65. Topcare All Day Allergy
66. Sun Mark All Day Allergy
67. Children's Zyrtec Allergy
68. Unii-64o047ktoa
69. Cetirizine Hydrochloride Hives
70. Cetirizine Di
71. Children's Zyrtec Hives Relief
72. Sr-01000688282
73. Cetirizine Hydrochloride Allergy
74. Cetirizine 2hcl
75. Up And Up All Day Allergy Relief
76. Prestwick_841
77. Cetirizine Hydrochloride [usan:usp]
78. Xyzal Dihydrochloride
79. Zyrtec (tn)
80. Quzyttir
81. 774596-22-4
82. Ox-nla
83. Children's Cetirizine Hydrochloride Allergy
84. Ncgc00016949-01
85. Cetirizine-d8 Hydrochloride
86. Cas-83881-52-1
87. Children's Cetirizine Hydrochloride Hives Relief
88. (+-)-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid, Dihydrochloride
89. Schembl41107
90. Spectrum1505371
91. Chebi:3562
92. Ucb P071
93. Cetirizine Hydrochloride (1:2)
94. Chembl1607273
95. Dtxsid2044268
96. Hms1569f07
97. Hms1922h04
98. Bcp09018
99. Tox21_110704
100. Tox21_302261
101. Tox21_500362
102. Hy-17042a
103. Mfcd00941428
104. S1291
105. Cetirizine Hydrochloride (jp17/usp)
106. Cetirizine Hydrochloride [jan]
107. Akos000280979
108. Akos016340521
109. Tox21_110704_1
110. Ac-1600
111. Ccg-213404
112. Cetirizine Dihydrochloride [mi]
113. Cs-1798
114. Ks-1042
115. Lp00362
116. Nsc 759102
117. Cetirizine Hydrochloride [mart.]
118. Cetirizine Hydrochloride [vandf]
119. Cetirizine Hydrochloride [usp-rs]
120. Cetirizine Hydrochloride [who-dd]
121. Ncgc00095180-01
122. Ncgc00095180-02
123. Ncgc00255965-01
124. Ncgc00261047-01
125. Ncgc00263567-01
126. Acetic Acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride, (+-)-
127. Bc164297
128. Cetirizine Dihydrochloride, >=98% (hplc)
129. Db-056756
130. (r)-cetirizine Dihcl (levocetirizine Dihcl)
131. Ft-0603000
132. Ft-0631130
133. Ft-0664487
134. Sw196972-3
135. Cetirizin Dihydrochloride, >=98.0% (hplc)
136. Cetirizine Hydrochloride [orange Book]
137. Cetirizine Hydrochloride [usp Monograph]
138. D00664
139. F20462
140. Cetirizine Dihydrochloride [ep Monograph]
141. 881c510
142. A840675
143. Zyrtec-d Component Cetirizine Hydrochloride
144. Sr-01000688282-3
145. Cetirizine Hydrochloride Component Of Zyrtec-d
146. Q27263769
147. Cetirizine Dihydrochloride 1.0 Mg/ml In Water (as Free Base)
148. Cetirizine Dihydrochloride, European Pharmacopoeia (ep) Reference Standard
149. Cetirizine Hydrochloride, British Pharmacopoeia (bp) Reference Standard
150. (rs)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy}-acetic Acid Dihydrochloride
151. [2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]aceticaciddihydrochloride
152. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid 2hcl
153. 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)aceticaciddihydrochloride
154. Cetirizine Dihydrochloride, United States Pharmacopeia (usp) Reference Standard
155. Cetirizine For Peak Identification, European Pharmacopoeia (ep) Reference Standard
156. Cetirizine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
157. (+) {2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazine-1-yl] -ethoxy}-acetic Acid Dihydrochloride
158. (+/-)-(2-(4-(p-chloro-a-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid, Dihydrochloride
159. (+/-){2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]-ethoxy}-acetic Acid Dihydrochloride
160. (rs)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy }-acetic Acid Dihydrochloride
161. 2-(2-(4-(p-chloro-alpha-phenylbenzyl)1-piperazinyl)ethoxy) Acetic Acid Dihydrochloride
162. 2-(2-{4-[(4-chlorophenyl)(phenyl)-methyl]piperazino}ethoxy)acetic Acid Dihydrochloride;cetirizine Dihydrochloride
163. Acetic Acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride, (+/-)-
164. Acetic Acid, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, Hydrochloride (1:2)
165. Cetirizine Dihydrochloride Solution, 1.0 Mg/ml In Acetonitrile: Water (9:1) (as Free Base), Ampule Of 1 Ml, Certified Reference Material
1. Cetirizin Dihydrochloride
2. Cetirizine Hcl
| Molecular Weight | 461.8 g/mol |
|---|---|
| Molecular Formula | C21H27Cl3N2O3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 8 |
| Exact Mass | 460.108726 g/mol |
| Monoisotopic Mass | 460.108726 g/mol |
| Topological Polar Surface Area | 53 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 443 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride |
| Drug Label | Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is () - [2- [4- [ (4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic comp... |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Perrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro |
| 2 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Capsule; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Wockhardt; Ranbaxy; Amneal Pharms Ny; Ipca Labs; Unichem; Apotex; Contract Pharmacal; Sun Pharm Inds; Taro; Torrent Pharms; Cadista Pharms; Dr Reddys Labs; Sandoz; Unique Pharm Labs; Banner Pharmacaps; Cipla; Orchid Hlthcare; Mylan |
| 3 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride hives |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Ranbaxy; Ipca Labs; Unichem; Sun Pharm Inds; Cadista Pharms; Dr Reddys Labs; Unique Pharm Labs; Orchid Hlthcare; Mylan |
| 4 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 5 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 6 of 20 | |
|---|---|
| Drug Name | Children's zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 7 of 20 | |
|---|---|
| Drug Name | Children's zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 8 of 20 | |
|---|---|
| Drug Name | Zyrtec |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Mcneil Consumer |
| 9 of 20 | |
|---|---|
| Drug Name | Zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Tablet, orally disintegrating |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 10 of 20 | |
|---|---|
| Drug Name | Zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 11 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride |
| Drug Label | Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is () - [2- [4- [ (4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic comp... |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Perrigo R And D; Amneal Pharms; Wockhardt; Silarx; Teva Pharms; Caraco; Breckenridge Pharm; Bio Pharm; Vintage; Taro |
| 12 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Capsule; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Wockhardt; Ranbaxy; Amneal Pharms Ny; Ipca Labs; Unichem; Apotex; Contract Pharmacal; Sun Pharm Inds; Taro; Torrent Pharms; Cadista Pharms; Dr Reddys Labs; Sandoz; Unique Pharm Labs; Banner Pharmacaps; Cipla; Orchid Hlthcare; Mylan |
| 13 of 20 | |
|---|---|
| Drug Name | Cetirizine hydrochloride hives |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Ranbaxy; Ipca Labs; Unichem; Sun Pharm Inds; Cadista Pharms; Dr Reddys Labs; Unique Pharm Labs; Orchid Hlthcare; Mylan |
| 14 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 15 of 20 | |
|---|---|
| Drug Name | Children's cetirizine hydrochloride hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup; Tablet, chewable |
| Route | Oral |
| Strength | 5mg; 10mg; 5mg/5ml |
| Market Status | Over the Counter |
| Company | Perrigo R And D; Amneal Pharms; Silarx; Cypress Pharm; Caraco; Bio Pharm; Aurobindo Pharma; Taro; Sun Pharma Global; Tris Pharma |
| 16 of 20 | |
|---|---|
| Drug Name | Children's zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 17 of 20 | |
|---|---|
| Drug Name | Children's zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 18 of 20 | |
|---|---|
| Drug Name | Zyrtec |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 5mg/5ml |
| Market Status | Prescription |
| Company | Mcneil Consumer |
| 19 of 20 | |
|---|---|
| Drug Name | Zyrtec allergy |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet; Tablet, orally disintegrating |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
| 20 of 20 | |
|---|---|
| Drug Name | Zyrtec hives relief |
| Active Ingredient | Cetirizine hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Over the Counter |
| Company | Mcneil Consumer |
Histamine H1 Antagonists, Non-Sedating
A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)
Anti-Allergic Agents
Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)
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DMF Number : 39199
Submission : 2024-02-06
Status : Active
Type : II
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2021-11-08
Registration Number : 20050831-40-C-139-01(7)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist-Ratnagiri 415722, Maharashtra State, India
| Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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DMF Review : Reviewed
Rev. Date : 2017-03-03
Pay. Date : 2017-02-08
DMF Number : 16244
Submission : 2002-11-14
Status : Active
Type : II
Certificate Number : CEP 2004-047 - Rev 08
Issue Date : 2024-09-30
Type : Chemical
Substance Number : 1084
Status : Valid
Registration Number : 218MF10400
Registrant's Address : Offer Park, Building C, 4th floor, 94 Shlomo Shmeltzer Road, POB 3158, Petah Tikva 4970602, Israel
Initial Date of Registration : 2006-04-14
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Sangjin Trading Co., Ltd.
Registration Date : 2008-06-27
Registration Number : 20080627-40-C-243-10
Manufacturer Name : Dr. Reddy\'s Laboratories Ltd
Manufacturer Address : Chemical Technical Operations, Unit-III Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District- 502 325, Telangana State, India.
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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DMF Review : Reviewed
Rev. Date : 2016-03-23
Pay. Date : 2015-12-14
DMF Number : 30063
Submission : 2016-02-01
Status : Active
Type : II
NDC Package Code : 62207-001
Start Marketing Date : 2016-12-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/1)
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Aspen Cetirizine 1 Mg/Ml
Dosage Form : SOL
Dosage Strength : 1mg/ml
Packaging : 150X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Allermine Soft Gel Capsules
Dosage Form : CAP
Dosage Strength : 10mg
Packaging : 25X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Cetirizina Pensa
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2005-02-09
Application Number : 66606
Regulatory Info : Authorized
Registration Country : Spain
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : OTC
Registration Country : USA
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2017-12-22
Application Number : 209274
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZYRTEC
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1996-09-27
Application Number : 20346
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Brand Name : ZYRTEC ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2007-11-16
Application Number : 19835
Regulatory Info : OTC
Registration Country : USA
Portfolio PDF
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Regulatory Info : OTC
Registration Country : USA
Brand Name : ZYRTEC ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2007-11-16
Application Number : 19835
Regulatory Info : OTC
Registration Country : USA
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZYRTEC HIVES
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2007-11-16
Application Number : 19835
Regulatory Info : DISCN
Registration Country : USA
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Website
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZYRTEC HIVES
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2007-11-16
Application Number : 19835
Regulatory Info : DISCN
Registration Country : USA
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Website
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Regulatory Info : OTC
Registration Country : USA
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : ZYRTEC-D 12 HOUR
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG;120MG
Packaging :
Approval Date : 2007-11-09
Application Number : 21150
Regulatory Info : OTC
Registration Country : USA
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2017-12-22
Application Number : 209274
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML
Approval Date : 2010-02-02
Application Number : 78617
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE HIVES
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2014-03-11
Application Number : 202277
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML
Approval Date : 2019-03-13
Application Number : 210622
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE HIVES
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2007-12-27
Application Number : 78336
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML
Approval Date : 2008-04-22
Application Number : 90188
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2007-12-27
Application Number : 77499
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG;120MG
Approval Date : 2012-09-28
Application Number : 90922
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2010-04-15
Application Number : 79191
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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Regulatory Info :
Registration Country : India
Cetirizine Dihydrochloride; Novafed
Brand Name :
Dosage Form : ER Tablet
Dosage Strength : 5MG; 120MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Cetirizine Dihydrochloride; Novafed
Dosage : ER Tablet
Dosage Strength : 5MG; 120MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic CTD, ACTD, BE
Registration Country : India
Brand Name : Zodac
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic CTD, ACTD, BE
Registration Country : India
Packaging :
Regulatory Info : Generic CTD, ACTD, BE
Dosage : TABLET
Dosage Strength : 5MG
Brand Name : Zodac
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : China
Cetirizine Dihydrochloride; Novafed
Brand Name :
Dosage Form : SR Capsule
Dosage Strength : 5MG; 120MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Cetirizine Dihydrochloride; Novafed
Dosage : SR Capsule
Dosage Strength : 5MG; 120MG
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : Russia
Brand Name :
Dosage Form : Drop
Dosage Strength : 10.00MG
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Russia
Packaging :
Regulatory Info :
Dosage : Drop
Dosage Strength : 10.00MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Russia
Regulatory Info :
Registration Country : India
Cetirizine HCl; Acetaminophen/Paracetamol; Phenylephrine Hydrochloride
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5MG; 325MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Cetirizine HCl; Acetaminophen/Paracetamol; Phenylephrine Hydrochloride
Dosage : Tablet
Dosage Strength : 5MG; 325MG; 5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Packaging :
Regulatory Info : Generic EU CTD
Dosage : TABLET
Dosage Strength : 5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Vietnam
Brand Name : Cezti
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Vietnam
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 10MG
Brand Name : Cezti
Approval Date :
Application Number :
Registration Country : Vietnam
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 22155
DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 22429
DOSAGE - CAPSULE;ORAL - 5MG
USFDA APPLICATION NUMBER - 22429
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61
PharmaCompass offers a list of Cetirizine Dihydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cetirizine Dihydrochloride manufacturer or Cetirizine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cetirizine Dihydrochloride manufacturer or Cetirizine Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Cetirizine Dihydrochloride API Price utilized in the formulation of products. Cetirizine Dihydrochloride API Price is not always fixed or binding as the Cetirizine Dihydrochloride Price is obtained through a variety of data sources. The Cetirizine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cetirizine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetirizine HCl, including repackagers and relabelers. The FDA regulates Cetirizine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetirizine HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cetirizine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetirizine HCl supplier is an individual or a company that provides Cetirizine HCl active pharmaceutical ingredient (API) or Cetirizine HCl finished formulations upon request. The Cetirizine HCl suppliers may include Cetirizine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Cetirizine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetirizine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetirizine HCl active pharmaceutical ingredient (API) in detail. Different forms of Cetirizine HCl DMFs exist exist since differing nations have different regulations, such as Cetirizine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetirizine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Cetirizine HCl USDMF includes data on Cetirizine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetirizine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetirizine HCl suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Cetirizine HCl Drug Master File in Japan (Cetirizine HCl JDMF) empowers Cetirizine HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Cetirizine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Cetirizine HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Cetirizine HCl suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Cetirizine HCl Drug Master File in Korea (Cetirizine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cetirizine HCl. The MFDS reviews the Cetirizine HCl KDMF as part of the drug registration process and uses the information provided in the Cetirizine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cetirizine HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Cetirizine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cetirizine HCl suppliers with KDMF on PharmaCompass.
A Cetirizine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Cetirizine HCl Certificate of Suitability (COS). The purpose of a Cetirizine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cetirizine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cetirizine HCl to their clients by showing that a Cetirizine HCl CEP has been issued for it. The manufacturer submits a Cetirizine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cetirizine HCl CEP holder for the record. Additionally, the data presented in the Cetirizine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cetirizine HCl DMF.
A Cetirizine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cetirizine HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cetirizine HCl suppliers with CEP (COS) on PharmaCompass.
A Cetirizine HCl written confirmation (Cetirizine HCl WC) is an official document issued by a regulatory agency to a Cetirizine HCl manufacturer, verifying that the manufacturing facility of a Cetirizine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cetirizine HCl APIs or Cetirizine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Cetirizine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Cetirizine HCl suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cetirizine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cetirizine HCl API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Cetirizine HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Cetirizine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cetirizine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cetirizine HCl suppliers with NDC on PharmaCompass.
Cetirizine HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Cetirizine HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Cetirizine HCl GMP manufacturer or Cetirizine HCl GMP API supplier for your needs.
A Cetirizine HCl CoA (Certificate of Analysis) is a formal document that attests to Cetirizine HCl's compliance with Cetirizine HCl specifications and serves as a tool for batch-level quality control.
Cetirizine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Cetirizine HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Cetirizine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetirizine HCl EP), Cetirizine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetirizine HCl USP).
