GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9834
Submission : 1992-08-24
Status : Inactive
Type : IV
NDC Package Code : 51552-1287
Start Marketing Date : 2012-01-02
End Marketing Date : 2025-12-11
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
FINISHED DOSAGE FORMULATIONS
Drug : LAMIVUDINE
Dosage Form : TABLET; ORAL
Application Number : 203260
Country : US
Patented : No
Drug : LAMIVUDINE
Dosage Form : TABLET; ORAL
Application Number : 203277
Country : US
Patented : No
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Drug : FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
Dosage Form : TABLET, CHEWABLE; ORAL
Application Number : 204782
Country : US
Patented : No
Drug : GONITRO
Dosage Form : POWDER; SUBLINGUAL
Application Number : 208424
Country : US
Patented : Yes
EXCIPIENTS BY APPLICATIONS
MARKET PLACE
REF. STANDARDS & IMPURITIES