Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212067
Company: UNICHEM
Company: UNICHEM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | AB | No | No |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | AB | No | No |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/09/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BACLOFEN
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 212378 | ANDAS 5 HOLDING |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 214099 | AUROBINDO PHARMA LTD |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077068 | ENDO OPERATIONS |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 217788 | GRAVITI PHARMS |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 072234 | IVAX SUB TEVA PHARMS |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077241 | LANNETT CO INC |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 215885 | MANKIND PHARMA |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 217687 | MICRO LABS |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 078401 | NORTHSTAR HLTHCARE |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 078504 | NORTHSTAR HLTHCARE |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077088 | OXFORD PHARMS |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 214374 | RISING PHARMA |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 209102 | RUBICON |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 212067 | UNICHEM |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 074584 | UPSHER SMITH LABS |
BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 211659 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 212378 | ANDAS 5 HOLDING |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 214099 | AUROBINDO PHARMA LTD |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077068 | ENDO OPERATIONS |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 217788 | GRAVITI PHARMS |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 072235 | IVAX SUB TEVA PHARMS |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077241 | LANNETT CO INC |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 215885 | MANKIND PHARMA |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 217687 | MICRO LABS |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 078401 | NORTHSTAR HLTHCARE |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077088 | OXFORD PHARMS |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 214374 | RISING PHARMA |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 209102 | RUBICON |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 212067 | UNICHEM |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 074584 | UPSHER SMITH LABS |
BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 211659 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 212378 | ANDAS 5 HOLDING |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 077241 | LANNETT CO INC |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 215885 | MANKIND PHARMA |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 217687 | MICRO LABS |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 214374 | RISING PHARMA |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 209102 | RUBICON |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 212067 | UNICHEM |
BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 211659 | ZYDUS LIFESCIENCES |