Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206751
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | AB | No | No |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 8MG | TABLET;ORAL | Prescription | AB | No | No |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 16MG | TABLET;ORAL | Prescription | AB | No | No |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 32MG | 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 |
---|---|---|---|---|---|---|---|
04/23/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
METHYLPREDNISOLONE
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROL | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 011153 | PFIZER |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040183 | ENDO OPERATIONS |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040189 | JUBILANT CADISTA |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040194 | SANDOZ |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 204072 | TIANJIN TIANYAO |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040232 | WATSON LABS |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 206751 | ZYDUS PHARMS |
TABLET;ORAL; 8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROL | METHYLPREDNISOLONE | 8MG | TABLET;ORAL | Prescription | Yes | AB | 011153 | PFIZER |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 8MG | TABLET;ORAL | Prescription | No | AB | 040189 | JUBILANT CADISTA |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 8MG | TABLET;ORAL | Prescription | No | AB | 206751 | ZYDUS PHARMS |
TABLET;ORAL; 16MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROL | METHYLPREDNISOLONE | 16MG | TABLET;ORAL | Prescription | Yes | AB | 011153 | PFIZER |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 16MG | TABLET;ORAL | Prescription | No | AB | 040189 | JUBILANT CADISTA |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 16MG | TABLET;ORAL | Prescription | No | AB | 206751 | ZYDUS PHARMS |
TABLET;ORAL; 32MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROL | METHYLPREDNISOLONE | 32MG | TABLET;ORAL | Prescription | Yes | AB | 011153 | PFIZER |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 32MG | TABLET;ORAL | Prescription | No | AB | 040189 | JUBILANT CADISTA |
METHYLPREDNISOLONE | METHYLPREDNISOLONE | 32MG | TABLET;ORAL | Prescription | No | AB | 206751 | ZYDUS PHARMS |