Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070985
Company: MERRO PHARM

Products on ANDA 070985

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070985

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/1987	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
07/31/2017	SUPPL-25	Labeling-Container/Carton Labels		Label is not available on this site.
06/08/2001	SUPPL-23	Labeling		Label is not available on this site.
06/08/2001	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/09/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
01/14/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-18	Labeling		Label is not available on this site.
08/28/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/15/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/13/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/19/1994	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/03/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/03/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/04/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/04/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.