Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085261
Company: ANI PHARMS

Products on ANDA 085261

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOPHYLLINE	AMINOPHYLLINE	200MG	TABLET;ORAL	Discontinued	None	No	No
AMINOPHYLLINE	AMINOPHYLLINE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085261

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1976	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
01/06/1995	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
12/10/1990	SUPPL-56	Labeling		Label is not available on this site.
11/30/1989	SUPPL-55	Labeling		Label is not available on this site.
11/30/1989	SUPPL-54	Labeling		Label is not available on this site.
06/19/1987	SUPPL-53	Manufacturing (CMC)		Label is not available on this site.
06/19/1987	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
06/19/1987	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
06/19/1987	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
08/23/1984	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
08/23/1984	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
02/03/1984	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
11/02/1982	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
05/24/1982	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
12/21/1981	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
12/21/1981	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.