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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090584
Company: SAGENT PHARMS

Products on ANDA 090584

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090584

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2012	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
05/01/2015	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090584

FLUMAZENIL

INJECTABLE;INJECTION; 0.5MG/5ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076755	BAXTER HLTHCARE CORP
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076955	FRESENIUS KABI USA
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076256	HIKMA
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076787	HIKMA
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078527	HIKMA FARMACEUTICA
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078595	RISING
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090584	SAGENT PHARMS
FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077071	SANDOZ INC

INJECTABLE;INJECTION; 1MG/10ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076755	BAXTER HLTHCARE CORP
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076955	FRESENIUS KABI USA
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076256	HIKMA
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076787	HIKMA
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078527	HIKMA FARMACEUTICA
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090584	SAGENT PHARMS
FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077071	SANDOZ INC

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