Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078213
Company: NORTHSTAR HLTHCARE
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
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB No No
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG 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
01/10/2008 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
06/11/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

06/11/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/27/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/01/2011 SUPPL-3 Labeling

Label is not available on this site.

12/15/2008 SUPPL-1 Labeling

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

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

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English