Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089247
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 12/04/1985 | 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 |
|---|---|---|---|---|---|
| 12/20/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/24/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 05/20/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/14/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/10/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/06/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/06/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/12/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/01/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
PREDNISONE
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; 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 |