Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040256
Company: VINTAGE PHARMS
Company: VINTAGE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
PREDNISONE | PREDNISONE | 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 |
---|---|---|---|---|---|---|---|
07/12/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40256ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/16/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/20/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
PREDNISONE
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 | 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 | 040256 | VINTAGE PHARMS |
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 | 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 | 040256 | VINTAGE PHARMS |
PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 085162 | WATSON LABS |