Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070213
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET;ORAL Prescription AB No No
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 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
11/19/1985 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
11/05/2004 SUPPL-23 Labeling

Label is not available on this site.

04/03/2002 SUPPL-20 Labeling

Label is not available on this site.

11/24/1999 SUPPL-19 Labeling

Label is not available on this site.

08/10/1998 SUPPL-18 Labeling

Label is not available on this site.

02/25/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/16/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/02/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/16/1991 SUPPL-12 Labeling

Label is not available on this site.

08/23/1990 SUPPL-11 Labeling

Label is not available on this site.

05/11/1990 SUPPL-10 Labeling

Label is not available on this site.

08/07/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/12/1989 SUPPL-8 Labeling

Label is not available on this site.

08/07/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/01/1989 SUPPL-6 Labeling

Label is not available on this site.

02/20/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/19/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROPRANOLOL HYDROCHLORIDE

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; 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; 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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