Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050617
Company: MYLAN

Products on NDA 050617

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYGEL	ERYTHROMYCIN	2%	GEL;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050617

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/1987	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2002	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/11/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/10/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/08/1997	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1997	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/1995	SUPPL-5	Labeling		Label is not available on this site.
01/03/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/18/1993	SUPPL-2	Labeling		Label is not available on this site.
06/30/1993	SUPPL-1	Efficacy-New Dosing Regimen		Label is not available on this site.

Therapeutic Equivalents for NDA 050617

ERYGEL

GEL;TOPICAL; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYGEL	ERYTHROMYCIN	2%	GEL;TOPICAL	Prescription	Yes	AT	050617	MYLAN
ERYTHROMYCIN	ERYTHROMYCIN	2%	GEL;TOPICAL	Prescription	No	AT	064184	FOUGERA PHARMS
ERYTHROMYCIN	ERYTHROMYCIN	2%	GEL;TOPICAL	Prescription	No	AT	063211	PADAGIS US