Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062935
Company: STRIDES PHARMA

Products on ANDA 062935

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062935

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/1988	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
07/09/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/06/1994	SUPPL-5	Labeling		Label is not available on this site.
05/18/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/04/1992	SUPPL-3	Labeling		Label is not available on this site.
12/04/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/01/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062935

PENICILLIN V POTASSIUM

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065435	AUROBINDO PHARMA
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	090549	HIKMA PHARMS
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	064071	SANDOZ
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	062935	STRIDES PHARMA
PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	060711	TEVA