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): 078527
Company: HIKMA FARMACEUTICA

Products on ANDA 078527

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078527

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

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

Top