Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074479
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/21/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074479ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2001 SUPPL-9 Labeling

Label is not available on this site.

04/12/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

09/19/2000 SUPPL-7 Labeling

Label is not available on this site.

03/21/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

05/21/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/14/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/20/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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