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 : 34077
Submission : 2019-08-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
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 : 28892
Submission : 2014-12-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-314 - Rev 01
Issue Date : 2023-05-09
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39750
Submission : 2024-03-27
Status : Active
Type : IV
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
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 : 11070
Submission : 1994-08-30
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30698
Submission : 2016-05-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29310
Submission : 2015-04-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27417
Submission : 2013-08-14
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28407
Submission : 2014-06-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30221
Submission : 2016-02-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28892
Submission : 2014-12-03
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15818
Submission : 2002-01-14
Status : Inactive
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
VMF Number : 78
Submission : 1971-03-24
Status : Inactive
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : KETEK
Dosage Form : TABLET; ORAL
Application Number : 21144
Country : US
Patented : No
Drug : ARAVA
Dosage Form : TABLET; ORAL
Application Number : 20905
Country : US
Patented : No
Drug : AMARYL
Dosage Form : TABLET; ORAL
Application Number : 20496
Country : US
Patented : No
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
Drug : RIFATER
Dosage Form : TABLET; ORAL
Application Number : 50705
Country : US
Patented : No
Drug : MAVIK
Dosage Form : TABLET; ORAL
Application Number : 20528
Country : US
Patented : No
Drug : BIAXIN XL
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 50775
Country : US
Patented : No
Drug : NIASPAN TITRATION STARTER PACK
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20381
Country : US
Patented : No
Drug : BIAXIN
Dosage Form : FOR SUSPENSION; ORAL
Application Number : 50698
Country : US
Patented : No
Drug : NIASPAN
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20381
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
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