Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040189
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
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 |
---|---|---|---|---|---|---|---|
10/31/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/14/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/05/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
09/05/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/19/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
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03/19/1998 | SUPPL-1 | Manufacturing (CMC) |
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 |