Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090549
Company: HIKMA PHARMS

Products on ANDA 090549

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	AB	No	No
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 090549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2013	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090549

PENICILLIN V POTASSIUM

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