Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013055
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORFLEX ORPHENADRINE CITRATE 30MG/ML INJECTABLE;INJECTION 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
10/02/1960 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013055s021ltr.pdf
06/04/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/22/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/24/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/22/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/29/1978 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1975 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/11/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf

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