Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040091
Company: EPIC PHARMA LLC

Products on ANDA 040091

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFADIAZINE	SULFADIAZINE	500MG	TABLET;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040091

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1994	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
09/20/2002	SUPPL-8	Labeling		Label is not available on this site.
02/02/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
06/17/1998	SUPPL-6	Labeling		Label is not available on this site.
07/21/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/21/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/08/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/09/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.