Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012157
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORFLEX ORPHENADRINE CITRATE 100MG TABLET, EXTENDED RELEASE;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
11/04/1959 ORIG-1 Approval Type 2 - New Active Ingredient 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
04/02/2007 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012157s028ltr.pdf
09/12/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/26/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/13/1989 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/11/1995 SUPPL-22 Labeling

Label is not available on this site.

08/26/1980 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1980 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/13/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1975 SUPPL-12 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/02/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf

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