Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215672
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| PREDNISONE | PREDNISONE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040581 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 087801 | HIKMA |
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 209727 | STRIDES PHARMA |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 213385 | AMNEAL |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 040256 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 212629 | GRANULATION TECH |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 080352 | HIKMA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 080292 | MYLAN |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 209727 | STRIDES PHARMA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 089247 | SUN PHARM INDUSTRIES |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 080356 | WATSON LABS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 213386 | AMNEAL |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 040256 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 212629 | GRANULATION TECH |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 084122 | HIKMA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 088832 | MYLAN |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 089247 | SUN PHARM INDUSTRIES |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 085162 | WATSON LABS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 213386 | AMNEAL |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 040392 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 212629 | GRANULATION TECH |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 087342 | HIKMA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 083677 | MYLAN |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 089247 | SUN PHARM INDUSTRIES |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 085161 | WATSON LABS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 084283 | HIKMA |
| PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |