Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040327
Company: SANDOZ

Products on ANDA 040327

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 040327

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40327ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/08/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/30/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/15/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 040327

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	091158	BAYSHORE PHARMS LLC
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