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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076216
Company: TARO

Products on ANDA 076216

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	LOTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2004	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076216

AMMONIUM LACTATE

LOTION;TOPICAL; EQ 12% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	LOTION;TOPICAL	Prescription	No	AB	075570	PADAGIS ISRAEL
AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	LOTION;TOPICAL	Prescription	No	AB	076216	TARO

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