Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRELONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 02/04/1986 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/089081_prelone_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/09/2002 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/05/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/29/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/28/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/15/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/10/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
PRELONE
SYRUP;ORAL; 15MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040323 | CHARTWELL RX |
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040775 | LANNETT CO INC |
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040571 | PHARM ASSOC |
| PRELONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 089081 | TEVA |