GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 78
Submission : 1966-09-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28892
Submission : 2014-12-03
Status : Active
Type : IV
Certificate Number : CEP 2025-278 - Rev 00
Issue Date : 2025-08-11
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-372 - Rev 00
Issue Date : 2021-02-05
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28407
Submission : 2014-06-12
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-196 - Rev 01
Issue Date : 2019-11-22
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27417
Submission : 2013-08-14
Status : Active
Type : IV
Certificate Number : CEP 2009-020 - Rev 01
Issue Date : 2024-03-26
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22604
Submission : 2009-01-19
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-079 - Rev 01
Issue Date : 2017-02-09
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32695
Submission : 2018-03-27
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-078 - Rev 01
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32698
Submission : 2018-11-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33415
Submission : 2018-12-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33592
Submission : 2019-02-21
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
MARKET PLACE
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17 Jan 2020
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17 Jun 2025
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27 May 2025
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28 Apr 2025
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10 Mar 2025
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07 Feb 2025
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08 Nov 2023
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24 Aug 2023
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29 May 2023
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10 May 2023
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21 Feb 2023
REF. STANDARDS & IMPURITIES