Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071415
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM INTENSOL DIAZEPAM 5MG/ML CONCENTRATE;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-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/20/2001 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/21/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/1998 SUPPL-7 Labeling

Label is not available on this site.

08/28/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/09/1994 SUPPL-5 Labeling

Label is not available on this site.

06/11/1990 SUPPL-4 Labeling

Label is not available on this site.

04/20/1989 SUPPL-2 Bioequivalence

Label is not available on this site.

01/26/1990 SUPPL-1 Labeling

Label is not available on this site.

DIAZEPAM INTENSOL

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 5MG/ML CONCENTRATE;ORAL Prescription No AA 204433 LANNETT CO INC
DIAZEPAM INTENSOL DIAZEPAM 5MG/ML CONCENTRATE;ORAL Prescription No AA 071415 WEST-WARD PHARMS INT

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