Application 021546
- Type
- NDA
- Sponsor
- SCHERING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REBETOL | RIBAVIRIN | SOLUTION;ORAL | 40MG/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0085-1318 | REBETOL | ribavirin | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1318 | REBETOL | ribavirin | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1318 | REBETOL | ribavirin | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1318 | REBETOL | ribavirin | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1318 | REBETOL | ribavirin | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70571 | SUPPL | 2022-03-21 |
| 70570 | SUPPL | 2022-03-21 |
| 70542 | SUPPL | 2022-03-17 |
| 61727 | SUPPL | 2020-01-29 |
| 61726 | SUPPL | 2020-01-29 |
| 61717 | SUPPL | 2020-01-29 |
| 58556 | SUPPL | 2019-05-03 |
| 58546 | SUPPL | 2019-05-03 |
| 15742 | SUPPL | 2015-05-27 |
| 28084 | SUPPL | 2015-05-22 |
| 37200 | SUPPL | 2013-11-22 |
| 28083 | SUPPL | 2013-11-18 |
| 15741 | SUPPL | 2013-06-04 |
| 5696 | SUPPL | 2013-06-04 |
| 37199 | SUPPL | 2013-02-08 |
| 28082 | SUPPL | 2013-02-08 |
| 5695 | SUPPL | 2011-05-10 |
| 5694 | SUPPL | 2010-11-03 |
| 37198 | SUPPL | 2010-10-29 |
| 28081 | SUPPL | 2010-01-20 |
| 37197 | SUPPL | 2009-11-16 |
| 42207 | ORIG | 2005-04-08 |
| 15740 | ORIG | 2004-06-14 |
| 5693 | ORIG | 2003-08-06 |