Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070736
Company: RISING

Products on ANDA 070736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Discontinued	None	No	No
IBUPROFEN	IBUPROFEN	300MG	TABLET;ORAL	Discontinued	None	No	No
IBUPROFEN	IBUPROFEN	400MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/1986	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
05/09/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
01/28/2000	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/12/1989	SUPPL-16	Labeling		Label is not available on this site.
01/19/1989	SUPPL-14	Labeling		Label is not available on this site.
03/01/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/13/1988	SUPPL-11	Labeling		Label is not available on this site.
06/29/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/17/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/13/1988	SUPPL-8	Labeling		Label is not available on this site.
04/06/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/04/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/16/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/16/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/07/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.