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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091158
Company: BAYSHORE PHARMS LLC

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	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

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