Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214734
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
01/21/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MIDODRINE HYDROCHLORIDE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 214734 | ALEMBIC |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 077746 | APOTEX |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 212774 | AUROBINDO PHARMA LTD |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207169 | ENDO OPERATIONS |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076449 | IMPAX PHARMS |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 217271 | MANKIND PHARMA |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076577 | MYLAN PHARMS INC |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211973 | NOVUGEN |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 212543 | RUBICON |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207613 | THINQ PHARM-CRO PVT |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207849 | XIROMED |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213055 | ZYDUS LIFESCIENCES |
ORVATEN | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076725 | UPSHER SMITH LABS |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 214734 | ALEMBIC |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077746 | APOTEX |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212774 | AUROBINDO PHARMA LTD |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207169 | ENDO OPERATIONS |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076449 | IMPAX PHARMS |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 217271 | MANKIND PHARMA |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076577 | MYLAN PHARMS INC |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 211973 | NOVUGEN |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212543 | RUBICON |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207613 | THINQ PHARM-CRO PVT |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207849 | XIROMED |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213055 | ZYDUS LIFESCIENCES |
ORVATEN | MIDODRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076725 | UPSHER SMITH LABS |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214734 | ALEMBIC |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077746 | APOTEX |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212774 | AUROBINDO PHARMA LTD |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207169 | ENDO OPERATIONS |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076449 | IMPAX PHARMS |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217271 | MANKIND PHARMA |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076577 | MYLAN PHARMS INC |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 211973 | NOVUGEN |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212543 | RUBICON |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207613 | THINQ PHARM-CRO PVT |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207849 | XIROMED |
MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213055 | ZYDUS LIFESCIENCES |
ORVATEN | MIDODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076725 | UPSHER SMITH LABS |