Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062847
Company: AUROBINDO PHARMA USA

Products on ANDA 062847

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062847

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/1988	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
12/10/2001	SUPPL-17	Labeling		Label is not available on this site.
02/23/2000	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/25/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/21/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/05/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/22/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/08/1993	SUPPL-9	Labeling		Label is not available on this site.
12/09/1991	SUPPL-8	Labeling		Label is not available on this site.
12/09/1991	SUPPL-7	Labeling		Label is not available on this site.
08/06/1991	SUPPL-6	Labeling		Label is not available on this site.
12/09/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/03/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/31/1990	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/17/1991	SUPPL-2	Labeling		Label is not available on this site.