Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070690
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/15/1987 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
06/16/2017 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

09/10/2008 SUPPL-20 Labeling

Label is not available on this site.

07/09/2008 SUPPL-19 Labeling

Label is not available on this site.

06/21/2007 SUPPL-17 Labeling

Label is not available on this site.

06/09/2004 SUPPL-14 Labeling

Label is not available on this site.

08/01/2001 SUPPL-13 Labeling

Label is not available on this site.

10/23/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/12/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/05/1994 SUPPL-8 Labeling

Label is not available on this site.

05/16/1991 SUPPL-7 Labeling

Label is not available on this site.

10/09/1990 SUPPL-6 Labeling

Label is not available on this site.

04/04/1990 SUPPL-5 Labeling

Label is not available on this site.

09/25/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/08/1990 SUPPL-1 Labeling

Label is not available on this site.

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