Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088126
Company: ROXANE

Products on ANDA 088126

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOPHYLLINE	AMINOPHYLLINE	105MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088126

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/1983	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
02/17/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/31/1998	SUPPL-16	Labeling		Label is not available on this site.
11/16/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/17/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-12	Labeling		Label is not available on this site.
08/01/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/26/1992	SUPPL-8	Labeling		Label is not available on this site.
10/03/1990	SUPPL-7	Labeling		Label is not available on this site.
03/22/1990	SUPPL-6	Labeling		Label is not available on this site.
04/06/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/18/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/18/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/22/1989	SUPPL-2	Labeling		Label is not available on this site.
10/24/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.