Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040192
Company: WE PHARMS
Company: WE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/28/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40192ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40192ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/16/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/16/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |