01 9AMNEAL
02 3ANDAS 5 HOLDING
03 1ANI PHARMS
04 2APPCO
05 2AUROBINDO PHARMA LTD
06 1AZURITY
07 3BEXIMCO PHARMS USA
08 2ENDO OPERATIONS
09 3EYWA
10 2GRAVITI PHARMS
11 2HERITAGE
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
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
01 3GRANULES;ORAL
02 22INJECTABLE;INTRATHECAL
03 3SOLUTION;ORAL
04 2SUSPENSION;ORAL
05 2TABLET, ORALLY DISINTEGRATING;ORAL
06 70TABLET;ORAL
01 26DISCN
02 72RX
03 4Blank
01 85BACLOFEN
02 1FLEQSUVY
03 4GABLOFEN
04 2KEMSTRO
05 5LIORESAL
06 3LYVISPAH
07 1OZOBAX
08 1OZOBAX DS
01 81No
02 17Yes
03 4Blank
RLD : Yes
TE Code : AP
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
RLD : Yes
TE Code : AP
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
RLD : Yes
TE Code : AP
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
RLD : Yes
TE Code :
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Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : Yes
TE Code :
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Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : Yes
TE Code : AP
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
RLD : Yes
TE Code : AP
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
RLD : Yes
TE Code : AP
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
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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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