Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070928
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/03/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/20/1999 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/1998 SUPPL-12 Labeling

Label is not available on this site.

09/10/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/03/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/09/1994 SUPPL-6 Labeling

Label is not available on this site.

02/01/1991 SUPPL-4 Labeling

Label is not available on this site.

01/26/1990 SUPPL-3 Labeling

Label is not available on this site.

12/23/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

DIAZEPAM

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION;ORAL Prescription No AA 070928 HIKMA
DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION;ORAL Prescription No AA 206477 LANNETT CO INC

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