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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087600
Company: AM REGENT

Products on ANDA 087600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOPHYLLINE	AMINOPHYLLINE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/1981	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
05/16/2023	SUPPL-28	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/23/2002	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/2002	SUPPL-21	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
10/01/1997	SUPPL-20	Labeling		Label is not available on this site.
11/14/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-18	Labeling		Label is not available on this site.
02/28/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/14/1994	SUPPL-16	Labeling		Label is not available on this site.
03/04/1994	SUPPL-15	Labeling		Label is not available on this site.
06/19/1990	SUPPL-14	Labeling		Label is not available on this site.
01/09/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/07/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/07/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/07/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/20/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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