Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIRAZOLE | RIBAVIRIN | 6GM/VIAL | FOR SOLUTION;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018859Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/06/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/12/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/04/1993 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1989 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1989 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1993 | SUPPL-3 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 08/27/1986 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/27/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |