Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070320
Company: INNOGENIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG 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
10/22/1985 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
08/04/1998 SUPPL-28 Labeling

Label is not available on this site.

12/01/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/19/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/26/1991 SUPPL-20 Labeling

Label is not available on this site.

05/25/1990 SUPPL-19 Bioequivalence

Label is not available on this site.

01/10/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/02/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/16/1988 SUPPL-15 Labeling

Label is not available on this site.

12/23/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/23/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/27/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/02/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/02/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/20/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/20/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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