Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070178
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB 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
05/13/1986 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
05/18/2015 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

07/14/2008 SUPPL-39 Labeling

Label is not available on this site.

05/03/2005 SUPPL-32 Labeling

Label is not available on this site.

06/27/2002 SUPPL-28 Labeling

Label is not available on this site.

04/25/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1999 SUPPL-26 Labeling

Label is not available on this site.

09/08/1998 SUPPL-24 Labeling

Label is not available on this site.

02/18/1993 SUPPL-22 Labeling

Label is not available on this site.

06/21/1991 SUPPL-19 Labeling

Label is not available on this site.

03/21/1991 SUPPL-18 Labeling

Label is not available on this site.

01/28/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-13 Labeling

Label is not available on this site.

05/08/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/08/1989 SUPPL-11 Labeling

Label is not available on this site.

06/03/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/03/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/22/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/22/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 071976 IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 078955 IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 070213 MYLAN
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 078213 NORTHSTAR HLTHCARE
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 070221 VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 070178 WATSON LABS

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 071976 IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 078955 IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 070213 MYLAN
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 078213 NORTHSTAR HLTHCARE
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 070221 VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 070178 WATSON LABS

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