Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060304
Company: TEVA

Products on ANDA 060304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/1964	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
02/10/2023	SUPPL-52	Labeling-Package Insert		Label is not available on this site.
08/13/2020	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
02/08/2012	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
12/03/2007	SUPPL-42	Labeling		Label is not available on this site.
11/04/2003	SUPPL-34	Labeling		Label is not available on this site.
02/27/2002	SUPPL-32	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
09/25/2000	SUPPL-31	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-30	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-29	Manufacturing (CMC)-Facility		Label is not available on this site.
06/18/1997	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
04/26/1996	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
10/26/1995	SUPPL-26	Labeling		Label is not available on this site.
02/16/1995	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/06/1994	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/11/1995	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/09/1993	SUPPL-22	Labeling		Label is not available on this site.
10/30/1992	SUPPL-21	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 060304

NEOMYCIN SULFATE

TABLET;ORAL; 500MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET;ORAL	Prescription	No	AA	060304	TEVA
NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET;ORAL	Prescription	No	AA	065220	XGEN PHARMS