Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013416
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORGESIC ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
NORGESIC FORTE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 770MG;60MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
03/04/1964 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/1999 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1997 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1995 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/05/1993 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1987 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/25/2002 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13416spd021ltr.pdf
01/31/1986 SUPPL-20 Labeling

Label is not available on this site.

07/27/1977 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/1977 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

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