Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072499
Company: INWOOD LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;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
04/11/1989 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
09/30/1998 SUPPL-9 Labeling

Label is not available on this site.

06/16/1998 SUPPL-8 Labeling

Label is not available on this site.

03/09/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/26/1998 SUPPL-6 Labeling

Label is not available on this site.

01/31/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/23/1993 SUPPL-4 Labeling

Label is not available on this site.

02/22/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/20/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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