Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083560
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG 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
08/05/1976 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
01/28/2000 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/27/1987 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/27/1987 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/06/1985 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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