An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012157
Company: BAUSCH

Products on NDA 012157

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORFLEX	ORPHENADRINE CITRATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012157

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.

Labels for NDA 012157

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

Top