Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071972
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG 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
04/06/1988 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
01/22/2015 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

12/09/2014 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

01/07/2008 SUPPL-24 Labeling

Label is not available on this site.

03/20/2008 SUPPL-23 Labeling

Label is not available on this site.

05/24/2002 SUPPL-11 Labeling

Label is not available on this site.

06/08/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

11/22/1999 SUPPL-8 Labeling

Label is not available on this site.

06/10/1999 SUPPL-7 Labeling

Label is not available on this site.

10/20/1998 SUPPL-6 Labeling

Label is not available on this site.

05/11/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/23/1992 SUPPL-4 Labeling

Label is not available on this site.

10/24/1991 SUPPL-3 Labeling

Label is not available on this site.

08/30/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 071972 IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078955 IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 070213 MYLAN
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078213 NORTHSTAR HLTHCARE
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 070221 VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 070175 WATSON LABS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 071972 IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 078955 IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 070213 MYLAN
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 078213 NORTHSTAR HLTHCARE
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 070221 VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 070176 WATSON LABS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 071972 IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 078955 IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 070213 MYLAN
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 078213 NORTHSTAR HLTHCARE
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 070219 VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 070221 VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 070177 WATSON LABS

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