Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064126
Company: PADAGIS US

Products on ANDA 064126

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	2%	SWAB;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064126

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/1996	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/064126ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2008	SUPPL-9	Labeling		Label is not available on this site.
09/16/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/2001	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
02/20/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/17/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/11/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 064126

ERYTHROMYCIN

SWAB;TOPICAL; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	2%	SWAB;TOPICAL	Prescription	No	AT	090215	EPIC PHARMA LLC
ERYTHROMYCIN	ERYTHROMYCIN	2%	SWAB;TOPICAL	Prescription	No	AT	064126	PADAGIS US