GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37745
Submission : 2022-11-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37656
Submission : 2022-11-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23613
Submission : 2010-03-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17995
Submission : 2004-12-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37199
Submission : 2022-06-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17763
Submission : 2004-09-28
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-222 - Rev 00
Issue Date : 2006-08-01
Type : TSE
Substance Number : 1474
Status : Valid
Certificate Number : R1-CEP 2001-081 - Rev 02
Issue Date : 2015-07-10
Type : TSE
Substance Number : 1474
Status : Valid
Certificate Number : R1-CEP 2001-001 - Rev 01
Issue Date : 2008-05-16
Type : TSE
Substance Number : 1474
Status : Valid
Certificate Number : R1-CEP 2000-278 - Rev 00
Issue Date : 2006-04-02
Type : TSE
Substance Number : 1474
Status : Valid
FINISHED DOSAGE FORMULATIONS
Drug : RENAGEL
Dosage Form : TABLET; ORAL
Application Number : 21179
Country : US
Patented : No
Drug : NIASPAN TITRATION STARTER PACK
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20381
Country : US
Patented : No
Drug : NIASPAN
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20381
Country : US
Patented : No
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Drug : VICODIN
Dosage Form : TABLET; ORAL
Application Number : 88058
Country : US
Patented : No
Drug : BIAXIN XL
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 50775
Country : US
Patented : No
Drug : BIAXIN
Dosage Form : FOR SUSPENSION; ORAL
Application Number : 50698
Country : US
Patented : No
Drug : BIAXIN
Dosage Form : TABLET; ORAL
Application Number : 50662
Country : US
Patented : No
Drug : TRETINOIN
Dosage Form : CREAM; TOPICAL
Application Number : 202209
Country : US
Patented : No
Drug : TRETINOIN
Dosage Form : CREAM; TOPICAL
Application Number : 90098
Country : US
Patented : No
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Drug : BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form : CAPSULE; ORAL
Application Number : 76560
Country : US
Patented : No
STEARIC ACID
Route : BUCCAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : BUCCAL/SUBLINGUAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 6
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : IMPLANTATION
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 0.2
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 52
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 3
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 3
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 3.23
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 15
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 21
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
STEARIC ACID
Route : ORAL
CAS : 57-11-4
UNII : 4ELV7Z65AP
Potency Amount : 1203
Potency Unit : MG/5ML
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Application : Lubricants & Glidants
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Application : Lubricants & Glidants
Excipient Details : Stearic acid is a saturated, wax-like, fatty acid commonly used in the production of pharmaceutical tablets and capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Dosage Form : Capsule, Granule / Pellet, Suppository, Tablet
Grade : Not Available
Category : Lubricants & Glidants
Application : Lubricants & Glidants
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Softgel Capsule
Grade : Not Available
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : Structure-building consistency factor with dry feel, forms crystalline barrier on skin
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP: Stearic ...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
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REF. STANDARDS & IMPURITIES
CAS Number : 57-11-4
Quantity Per Vial : 500
Sale Unit : mg
Price : $275.00
Details : Material Origin- Plant; USMCA- No; KORUS- No
Monograph :
Storage :
Code/Batch No : Catalog #1621008 / R03400