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Approved Drug Products containing Flumazenil listed in the FDA Orange Book. Original Data : FDA Website

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01 2DR REDDYS

02 2BAXTER HLTHCARE CORP

03 2FRESENIUS KABI USA

04 4HIKMA

05 2HIKMA FARMACEUTICA

06 2HOFFMANN LA ROCHE

07 2RISING

08 2SAGENT PHARMS

09 2SANDOZ

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/10ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76589

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/5ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76589

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/10ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76755

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/5ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76755

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : ROMAZICON

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-12-20

Application Number : 20073

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : ROMAZICON

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-12-20

Application Number : 20073

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/10ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76256

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/5ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76256

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1MG/10ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76787

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

FLUMAZENIL

Brand Name : FLUMAZENIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/5ML (0.1MG/ML)

Approval Date : 2004-10-12

Application Number : 76787

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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