Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071265
Company: ADAPTIS

Products on ANDA 071265

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071265

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/1986	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
03/21/2019	SUPPL-49	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/21/2019	SUPPL-48	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/21/2019	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
03/22/2006	SUPPL-27	Labeling		Label is not available on this site.
09/29/2004	SUPPL-25	Labeling		Label is not available on this site.
12/01/1999	SUPPL-23	Labeling		Label is not available on this site.
07/23/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/24/1996	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/28/1994	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/24/1993	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/23/1990	SUPPL-17	Bioequivalence		Label is not available on this site.
08/27/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/27/1991	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/18/1987	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/18/1987	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/18/1987	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/02/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/06/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/21/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/21/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/21/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/06/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/14/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.