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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087204
Company: LEGACY PHARMA

Products on ANDA 087204

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CROTAN	CROTAMITON	10%	LOTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1981	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
03/10/2014	SUPPL-6	Labeling		Label is not available on this site.
11/08/1994	SUPPL-2	Labeling		Label is not available on this site.
02/11/1992	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 087204

CROTAN

LOTION;TOPICAL; 10%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CROTAN	CROTAMITON	10%	LOTION;TOPICAL	Prescription	No	AT	087204	LEGACY PHARMA

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