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Application Number
Indian CDSCO WC-0293
Status
 
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2024-12-16
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Azithromycin BP/EP/USP
Issue/Submission Date
2022-11-02
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Application Number
28294
Status
Active
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Reviewed
 
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AZITHROMYCIN MONOHYDRATE USP
Issue/Submission Date
2015-03-02
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Application Number
15261
R1-CEP 2004-181 - Rev 03
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
AZITHROMYCIN MONOHYDRATE
Azithromycin, Monohydrate
Issue/Submission Date
2001-01-24
2020-02-03
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Application Number
15985
Status
Active
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AZITHROMYCIN N
Issue/Submission Date
2002-05-28
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Application Number
27295
Status
Inactive
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2013-07-10
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Application Number
20258
Status
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Fees Unpaid
N/A
 
Filing Details
AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2007-01-08
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Application Number
17010
Status
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Fees Paid
N/A
 
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AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2005-02-28
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Application Number
17091
R1-CEP 2014-118 - Rev 01
Indian CDSCO WC-0081
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2022-07-02
Filing Details
AZITHROMYCIN MONOHYDRATE
Azithromycin, Monohydrate
Azithromycin Monohydrate (EP)
Issue/Submission Date
2003-12-31
2023-03-10
2019-07-05
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Application Number
18719
Status
Active
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN MONOHYDRATE USP
Issue/Submission Date
2005-08-31
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Application Number
24754
Status
Active
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Reviewed
 
Filing Details
AZITHROMYCIN MONOHYDRATE USP (PROCE...
Issue/Submission Date
2011-02-01
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Application Number
19326
224MF10048
Indian CDSCO WC-0049
Status
Inactive
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
AZITHROMYCIN MONOHYDRATE USP
Azithromycin hydrate at Kalpataru I...
Azithromycin Monohydrate USP
Issue/Submission Date
2006-03-31
2012-03-12
2022-06-07
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Application Number
25820
Status
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AZITHROMYCIN MONOHYDRATE USP (PROCE...
Issue/Submission Date
2012-04-02
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Application Number
14480
Status
Inactive
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN USP
Issue/Submission Date
1999-10-14
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Application Number
16268
Status
Inactive
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN-FORM I
Issue/Submission Date
2002-11-25
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Application Number
18073
Status
Active
Fees Paid
N/A
 
Filing Details
ANHYDROUS AZITHROMYCIN
Issue/Submission Date
2005-02-11
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Application Number
23486
Status
Inactive
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN GRANULES FOR ORAL SUSP...
Issue/Submission Date
2010-01-27
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Application Number
27713
Status
Active
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2013-09-21
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Application Number
27067
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
AZITHROMYCIN TASTE MASKING GRANULES...
Issue/Submission Date
2013-03-15
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Application Number
17951
Status
Inactive
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN HYDROGENCITRATE
Issue/Submission Date
2004-12-29
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Application Number
20852
R1-CEP 2014-185 - Rev 00
224MF10166
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
AZITHROMYCIN MONHYDRATE, NON-STERIL...
Azithromycin, Monohydrate
Azithromycin hydrate at No. 62 Binj...
Issue/Submission Date
2007-09-10
2020-08-28
2012-08-16
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Application Number
16390
R1-CEP 2002-257 - Rev 01
224MF10040
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
AZITHROMYCIN MONOHYDRATE (NON-STERI...
Azithromycin, Monohydrate
Azithromycin hydrate at Ctra. Grano...
Issue/Submission Date
2003-01-30
2012-09-26
2012-02-28
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Application Number
28453
R0-CEP 2017-154 - Rev 00
Status
Active
Fees Paid
Reviewed
Withdrawn by Holder
 
Filing Details
AZITHROMYCIN MONOHYDRATE NON-STERIL...
Azithromycin, PII
Issue/Submission Date
2014-10-23
2017-10-26
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Application Number
29986
Indian CDSCO WC-0378A2
Status
Active
Fees Unpaid
N/A
 
Expired
2022-07-06
Filing Details
AZITHROMYCIN (LYOPHILIZED BULK STER...
Azithromycin IH
Issue/Submission Date
2016-11-28
2020-04-16
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Application Number
27885
Status
Active
Fees Unpaid
N/A
 
Filing Details
AZITHROMYCIN USP (DIHYDRATE)
Issue/Submission Date
2013-12-02
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Application Number
20074
302MF10065
Status
Inactive
Fees Paid
N/A
 
Filing Details
AZITHROMYCIN USP (API)
Azithromycin at No. 88 Yangzi Road,...
Issue/Submission Date
2006-12-18
2020-06-08
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Application Number
22331
Status
Active
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Filing Details
AZITHROMYCIN
Issue/Submission Date
2008-12-05
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Application Number
18868
R1-CEP 2007-118 - Rev 05
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
AZITHROMYCIN MONOHYDRATE USP
Azithromycin, Monohydrate
Issue/Submission Date
2005-10-14
2022-08-12
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Application Number
CEP 2021-069 - Rev 00
219MF10312
Status
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Filing Details
Azithromycin
Azithromycin hydrate at No. 1318 Ji...
Issue/Submission Date
2023-09-20
2007-10-05
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Application Number
Indian CDSCO WC-0090
Status
 
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2025-07-14
Filing Details
Azithromycin (EP)
Issue/Submission Date
2022-08-31
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Application Number
Indian CDSCO WC-0092
Status
 
Valid
2024-11-04
Filing Details
Azithromycin Monohydrate (Ph. Eur./...
Issue/Submission Date
2022-09-01
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Application Number
R0-CEP 2021-143 - Rev 00
Indian CDSCO WC-0086
Status
Valid
 
Expired
2023-03-01
Filing Details
Azithromycin
Azithromycin (BP/EP/LISP)
Issue/Submission Date
2023-07-13
2020-03-18
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Application Number
R1-CEP 2010-131 - Rev 02
219MF10049
Status
Valid
 
Filing Details
Azithromycin, Monohydrate
Azithromycin hydrate at Prilaz baru...
Issue/Submission Date
2021-10-27
2007-02-13
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Application Number
Indian CDSCO WC-0086A4
Status
 
Expired
2023-03-01
Filing Details
Azithromycin BP/EP
Issue/Submission Date
2020-07-06
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Application Number
Indian CDSCO WC-0024
Status
 
Valid
2025-06-28
Filing Details
Azithromycin IH/USP
Issue/Submission Date
2022-07-08
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Application Number
Indian CDSCO WC-0214
Status
 
Expired
2022-07-02
Filing Details
Azithromycin BP/EP/USP
Issue/Submission Date
2020-02-14
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Application Number
Indian CDSCO WC-0024A5
Status
 
Expired
2022-06-26
Filing Details
Azithromycin Anhydrous IH/USP
Issue/Submission Date
2022-06-23
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  • FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET
  • FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML
  • FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML
  • TABLET;ORAL - EQ 250MG BASE
  • TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
  • TABLET;ORAL - EQ 500MG BASE
  • FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

Looking for 83905-01-5 / Azithromycin API manufacturers, exporters & distributors?

Azithromycin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Azithromycin 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 Azithromycin manufacturer or Azithromycin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azithromycin manufacturer or Azithromycin supplier.

PharmaCompass also assists you with knowing the Azithromycin API Price utilized in the formulation of products. Azithromycin API Price is not always fixed or binding as the Azithromycin Price is obtained through a variety of data sources. The Azithromycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Azithromycin

Synonyms

Zithromax, 83905-01-5, Sumamed, Hemomycin, Azasite, Zitromax

Cas Number

83905-01-5

Unique Ingredient Identifier (UNII)

J2KLZ20U1M

About Azithromycin

A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

Azithromycin Hydrate Manufacturers

A Azithromycin Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azithromycin Hydrate, including repackagers and relabelers. The FDA regulates Azithromycin Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azithromycin Hydrate 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 Azithromycin Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Azithromycin Hydrate Suppliers

A Azithromycin Hydrate supplier is an individual or a company that provides Azithromycin Hydrate active pharmaceutical ingredient (API) or Azithromycin Hydrate finished formulations upon request. The Azithromycin Hydrate suppliers may include Azithromycin Hydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Azithromycin Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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