GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16213
Submission : 2002-10-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39460
Submission : 2024-02-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34780
Submission : 2020-07-09
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-169 - Rev 00
Issue Date : 2021-06-03
Type : Chemical
Substance Number : 625
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14993
Submission : 2000-08-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20497
Submission : 2007-04-24
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2014-341 - Rev 02
Issue Date : 2025-04-09
Type : Chemical
Substance Number : 625
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2023-334 - Rev 00
Issue Date : 2025-01-02
Type : Chemical
Substance Number : 625
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-182 - Rev 00
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 625
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39460
Submission : 2024-02-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20497
Submission : 2007-04-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14993
Submission : 2000-08-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16213
Submission : 2002-10-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34780
Submission : 2020-07-09
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-169 - Rev 00
Status : Valid
Issue Date : 2021-06-03
Type : Chemical
Substance Number : 625
Certificate Number : CEP 2023-334 - Rev 00
Status : Valid
Issue Date : 2025-01-02
Type : Chemical
Substance Number : 625
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2023-182 - Rev 00
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 625
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2014-341 - Rev 02
Status : Valid
Issue Date : 2025-04-09
Type : Chemical
Substance Number : 625
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FINISHED DOSAGE FORMULATIONS
Drug : DIABETA
Dosage Form : TABLET; ORAL
Application Number : 17532
Country : US
Patented : No
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Drug : TARKA
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 20591
Country : US
Patented : No
Drug : DICLOFENAC SODIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 74514
Country : US
Patented : No
Drug : RANOLAZINE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 201046
Country : US
Patented : No
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Drug : NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Dosage Form : CAPSULE; ORAL
Application Number : 76648
Country : US
Patented : No
Drug : GRISEOFULVIN
Dosage Form : SUSPENSION; ORAL
Application Number : 65200
Country : US
Patented : No
Drug : GRISEOFULVIN
Dosage Form : SUSPENSION; ORAL
Application Number : 65354
Country : US
Patented : No
Drug : GRISEOFULVIN
Dosage Form : SUSPENSION; ORAL
Application Number : 65438
Country : US
Patented : No
Drug : VERAPAMIL HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 90700
Country : US
Patented : No
Drug : VERAPAMIL HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 78906
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
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12 Jul 2023
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10 Apr 2020