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

Abbreviated New Drug Application (ANDA): 091158
Company: UNICHEM

Products on ANDA 091158

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091158

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2012	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091158

ORPHENADRINE CITRATE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040284	LUPIN
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040249	RISING
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	040327	SANDOZ
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091158	UNICHEM

Top