Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074931
Company: CONTRACT PHARMACAL

Products on ANDA 074931

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 074931

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74931_Ibuprofen_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74931ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074931_ibuprofen_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2000	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
05/03/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
05/03/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
07/24/2000	SUPPL-5	Labeling		Label is not available on this site.
08/16/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/16/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074931

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74931_Ibuprofen_Prntlbl.pdf