Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210048
Company: MAIA PHARMS INC
Company: MAIA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | No | No |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
09/11/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BACLOFEN
INJECTABLE;INTRATHECAL; 0.5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | AMNEAL |
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210048 | MAIA PHARMS INC |
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209592 | MYLAN LABS LTD |
BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 217324 | RUBICON |
GABLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
LIORESAL | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | AMNEAL |
INJECTABLE;INTRATHECAL; 2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | AMNEAL |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210048 | MAIA PHARMS INC |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209592 | MYLAN LABS LTD |
BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 217324 | RUBICON |
GABLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
LIORESAL | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | AMNEAL |