Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070028
Company: ANI PHARMS

Products on ANDA 070028

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1985	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
02/21/2025	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
06/24/2024	SUPPL-34	Labeling-Package Insert, Labeling		Label is not available on this site.
09/22/2022	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
09/22/2022	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
05/31/2002	SUPPL-31	Manufacturing (CMC)-Facility		Label is not available on this site.
08/30/2000	SUPPL-29	Labeling		Label is not available on this site.
05/29/2001	SUPPL-28	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/02/1999	SUPPL-26	Manufacturing (CMC)-Facility		Label is not available on this site.
12/02/1999	SUPPL-25	Manufacturing (CMC)-Facility		Label is not available on this site.
02/12/1999	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/12/1999	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/04/1998	SUPPL-20	Labeling		Label is not available on this site.
01/30/1998	SUPPL-19	Labeling		Label is not available on this site.
05/09/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/22/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/07/1994	SUPPL-9	Labeling		Label is not available on this site.
12/20/1990	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/20/1990	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/20/1990	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/28/1990	SUPPL-5	Labeling		Label is not available on this site.
06/28/1990	SUPPL-4	Labeling		Label is not available on this site.
04/28/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.