Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050529
Company: ROSS LABS
Company: ROSS LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEDIAZOLE | ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL | EQ 200MG BASE/5ML;EQ 600MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GRANULE;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 11/29/1979 | ORIG-1 | Approval | Type 3 - New Dosage Form and Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/09/2004 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50529slr033ltr.pdf |
| 06/21/1994 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1993 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1992 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1991 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 09/29/1992 | SUPPL-12 | Efficacy-New Indication |
Label is not available on this site. |