Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084655
Company: SCHWARZ PHARMA
Company: SCHWARZ PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNICEN-M | PREDNISONE | 5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/09/1975 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084655_prednicen-m_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/15/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/31/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/18/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/08/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |