Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021453
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZERIT XR | STAVUDINE | 37.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ZERIT XR | STAVUDINE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ZERIT XR | STAVUDINE | 75MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ZERIT XR | STAVUDINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/19/2005 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21453s004lbl.pdf | |
| 06/04/2004 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21453slr003_zerit_lbl.pdf | |
| 12/31/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21453_Zerit_lbl.pdf |