Drugs@FDA: FDA Approved Drug Products

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

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 076955 FRESENIUS KABI USA
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 MYLAN LABS LTD
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
FLUMAZENIL FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 076256 WEST-WARD PHARMS INT
FLUMAZENIL FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 076787 WEST-WARD PHARMS INT

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 076955 FRESENIUS KABI USA
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
FLUMAZENIL FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 076256 WEST-WARD PHARMS INT
FLUMAZENIL FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE;INJECTION Prescription No AP 076787 WEST-WARD PHARMS INT

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