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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060711
Company: TEVA

Products on ANDA 060711

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	AB	No	No
PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060711

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/1968	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
07/16/2014	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
04/30/2008	SUPPL-38	Labeling		Label is not available on this site.
09/25/2007	SUPPL-37	Labeling		Label is not available on this site.
11/13/2001	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/2001	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/15/2001	SUPPL-26	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-25	Manufacturing (CMC)-Facility		Label is not available on this site.
08/28/1996	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/24/1996	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/21/1995	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/02/1994	SUPPL-21	Labeling		Label is not available on this site.
08/25/1993	SUPPL-20	Labeling		Label is not available on this site.
08/25/1993	SUPPL-19	Labeling		Label is not available on this site.
02/26/1993	SUPPL-18	Labeling		Label is not available on this site.
03/09/1993	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/09/1993	SUPPL-16	Labeling		Label is not available on this site.
11/10/1988	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 060711

PENICILLIN-VK

TABLET;ORAL; EQ 250MG 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 250MG BASE	TABLET;ORAL	Prescription	No	AB	065435	AUROBINDO PHARMA
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	062936	CHARTWELL RX
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	090549	HIKMA PHARMS
PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	060711	TEVA

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	062935	CHARTWELL RX
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	090549	HIKMA PHARMS
PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	060711	TEVA

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