Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020942
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERSED | MIDAZOLAM HYDROCHLORIDE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/15/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20942_Versed_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020942_versed_toc.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/25/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/30/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/24/1999 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |