Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074312
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 1MG/ML CONCENTRATE;ORAL Prescription None 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
10/31/1993 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074312.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/28/2007 SUPPL-11 Labeling

Label is not available on this site.

09/05/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/21/2001 SUPPL-4 Labeling

Label is not available on this site.

08/12/1997 SUPPL-3 Labeling

Label is not available on this site.

08/28/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/07/1994 SUPPL-1 Labeling

Label is not available on this site.

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