Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062687
Company: MICRO LABS

Products on ANDA 062687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHRA-DERM	ERYTHROMYCIN	2%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062687

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/1988	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
02/11/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/05/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/03/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/01/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/02/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/02/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/10/1993	SUPPL-3	Labeling		Label is not available on this site.
01/14/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/19/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062687

ERYTHRA-DERM

SOLUTION;TOPICAL; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHRA-DERM	ERYTHROMYCIN	2%	SOLUTION;TOPICAL	Prescription	No	AT	062687	MICRO LABS
ERYTHROMYCIN	ERYTHROMYCIN	2%	SOLUTION;TOPICAL	Prescription	No	AT	063038	PADAGIS US