Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040463
Company: HIKMA

Products on ANDA 040463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	30MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2019	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
08/11/2008	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040463

ORPHENADRINE CITRATE

INJECTABLE;INJECTION; 30MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040463	HIKMA
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040484	RISING
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090585	SAGENT PHARMS
ORPHENADRINE CITRATE	ORPHENADRINE CITRATE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	084779	WATSON LABS