Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070301
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25MG;40MG 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
04/18/1986 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
04/28/1998 SUPPL-12 Labeling

Label is not available on this site.

01/31/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/01/1991 SUPPL-10 Labeling

Label is not available on this site.

03/21/1991 SUPPL-9 Labeling

Label is not available on this site.

08/02/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/07/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/24/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/10/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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