Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211555
Company: EYWA PHARMA
Company: EYWA PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 02/01/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2021 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/06/2020 | SUPPL-2 | Labeling-Package Insert |
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 | 214099 | AUROBINDO PHARMA LTD |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 211555 | EYWA PHARMA |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 217788 | GRAVITI PHARMS |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 212378 | INNOGENIX |
| 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 |
| 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 | 077068 | VINTAGE PHARMS |
| 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 | 214099 | AUROBINDO PHARMA LTD |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 211555 | EYWA PHARMA |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 217788 | GRAVITI PHARMS |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 212378 | INNOGENIX |
| 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 |
| 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 | 077068 | VINTAGE PHARMS |
| 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 | 214114 | BEXIMCO PHARMS USA |
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 211555 | EYWA PHARMA |
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 212378 | INNOGENIX |
| 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 |
| 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 |