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Approved Drug Products containing NCGC00024579-03 listed in the FDA Orange Book. Original Data : FDA Website

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01 2ACIC PHARMS

02 9AMNEAL

03 3ANDAS 5 HOLDING

04 1ANI PHARMS

05 2APPCO

06 2AUROBINDO PHARMA LTD

07 1AZURITY

08 3BEXIMCO PHARMS USA

09 2ENDO OPERATIONS

10 3EYWA

11 2GRAVITI PHARMS

12 3IMPAX

13 2IVAX SUB TEVA PHARMS

14 3LANNETT CO INC

15 4MAIA PHARMS INC

16 3MANKIND PHARMA

17 2METACEL PHARMS LLC

18 3MICRO LABS

19 3MYLAN LABS LTD

20 3NORTHSTAR HLTHCARE

21 3NORVIUM BIOSCIENCE

22 2NOVARTIS

23 2OXFORD PHARMS

24 4PIRAMAL CRITICAL

25 3RISING PHARMA

26 8RUBICON

27 2SUN PHARM INDS INC

28 2TEVA

29 2UCB INC

30 3UNICHEM

31 2UPSHER SMITH LABS

32 2USL PHARMA

33 6WATSON LABS

34 4ZYDUS LIFESCIENCES

35 1Blank

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PharmaCompass

01

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BACLOFEN

Brand Name : LIORESAL

Dosage Form : INJECTABLE;INTRATHECAL

Dosage Strength : 0.5MG/ML

Approval Date : 1992-06-17

Application Number : 20075

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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02

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BACLOFEN

Brand Name : LIORESAL

Dosage Form : INJECTABLE;INTRATHECAL

Dosage Strength : 2MG/ML

Approval Date : 1992-06-17

Application Number : 20075

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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03

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BACLOFEN

Brand Name : LIORESAL

Dosage Form : INJECTABLE;INTRATHECAL

Dosage Strength : 0.05MG/ML

Approval Date : 1996-11-07

Application Number : 20075

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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04

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BACLOFEN

Brand Name : LIORESAL

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 17851

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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BACLOFEN

Brand Name : LIORESAL

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-20

Application Number : 17851

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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BACLOFEN

Brand Name : GABLOFEN

Dosage Form : INJECTABLE;INTRATHECAL

Dosage Strength : 0.05MG/ML

Approval Date : 2010-11-19

Application Number : 22462

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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07

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BACLOFEN

Brand Name : GABLOFEN

Dosage Form : INJECTABLE;INTRATHECAL

Dosage Strength : 0.5MG/ML

Approval Date : 2010-11-19

Application Number : 22462

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

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BACLOFEN

Brand Name : GABLOFEN

Dosage Form : INJECTABLE;INTRATHECAL

Dosage Strength : 2MG/ML

Approval Date : 2010-11-19

Application Number : 22462

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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09

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BACLOFEN

Brand Name : KEMSTRO

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-10-30

Application Number : 21589

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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BACLOFEN

Brand Name : KEMSTRO

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-10-30

Application Number : 21589

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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