Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078504
Company: NORTHSTAR HLTHCARE
Company: NORTHSTAR HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 10MG | 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 |
---|---|---|---|---|---|---|---|
09/18/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/15/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/28/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
03/25/2010 | SUPPL-1 | Labeling-Container/Carton Labels |
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 |