Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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01 3MANKIND PHARMA
02 9AMNEAL
03 3ANDAS 5 HOLDING
04 1ANI PHARMS
05 3APPCO
06 2AUROBINDO PHARMA LTD
07 1AZURITY
08 3BEXIMCO PHARMS USA
09 2HERITAGE
10 3HIBROW HLTHCARE
11 3IMPAX
12 2IVAX SUB TEVA PHARMS
13 3LANNETT CO INC
14 4MAIA PHARMS INC
15 2METACEL PHARMS LLC
16 3MICRO LABS
17 3NORTHSTAR HLTHCARE
18 2NOVARTIS
19 2OXFORD PHARMS
20 2PH HEALTH
21 6PHARMOBEDIENT
22 4PIRAMAL CRITICAL
23 6RISING
24 9RUBICON RESEARCH
25 2SUN PHARM INDS INC
26 2TEVA
27 2UCB INC
28 3UNICHEM
29 2USL PHARMA
30 6WATSON LABS
31 2YILING
32 4ZYDUS LIFESCIENCES
33 1Blank
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01 3GRANULES;ORAL
02 22INJECTABLE;INTRATHECAL
03 4SOLUTION;ORAL
04 2SUSPENSION;ORAL
05 2TABLET, ORALLY DISINTEGRATING;ORAL
06 72TABLET;ORAL
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01 29DISCN
02 73RX
03 3Blank
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01 88BACLOFEN
02 1FLEQSUVY
03 4GABLOFEN
04 2KEMSTRO
05 5LIORESAL
06 3LYVISPAH
07 1OZOBAX
08 1OZOBAX DS
01 85No
02 17Yes
03 3Blank
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AB
Brand Name : BACLOFEN
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2022-01-25
Application Number : 215885
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AB
Brand Name : BACLOFEN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2022-01-25
Application Number : 215885
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
RLD : No
TE Code : AB
Brand Name : BACLOFEN
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date : 2022-01-25
Application Number : 215885
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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 :
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 :