Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074782
Company: CONTRACT PHARMACAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG CAPSULE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/06/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74782ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74782apTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2006 SUPPL-4 Labeling

Label is not available on this site.

10/27/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-2 Labeling

Label is not available on this site.

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