Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075883
Company: SUN PHARMA CANADA

Products on ANDA 075883

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075883

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075883.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2004	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075883

AMMONIUM LACTATE

CREAM;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	CREAM;TOPICAL	Prescription	No	AB	075774	PADAGIS ISRAEL
AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	CREAM;TOPICAL	Prescription	No	AB	075883	SUN PHARMA CANADA
AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	CREAM;TOPICAL	Prescription	No	AB	217815	ZYDUS LIFESCIENCES