Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040797
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEPROBAMATE | MEPROBAMATE | 200MG | TABLET;ORAL | Prescription | AA | No | No |
MEPROBAMATE | MEPROBAMATE | 400MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
02/27/2008 | ORIG-1 | Approval |
Label is not available on this site. |
MEPROBAMATE
TABLET;ORAL; 200MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEPROBAMATE | MEPROBAMATE | 200MG | TABLET;ORAL | Prescription | No | AA | 090122 | ALEMBIC PHARMS LTD |
MEPROBAMATE | MEPROBAMATE | 200MG | TABLET;ORAL | Prescription | No | AA | 040797 | INVAGEN PHARMS |
TABLET;ORAL; 400MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEPROBAMATE | MEPROBAMATE | 400MG | TABLET;ORAL | Prescription | No | AA | 090122 | ALEMBIC PHARMS LTD |
MEPROBAMATE | MEPROBAMATE | 400MG | TABLET;ORAL | Prescription | No | AA | 040797 | INVAGEN PHARMS |