Application 050747
- Type
- NDA
- Sponsor
- KING PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SYNERCID | QUINUPRISTIN; DALFOPRISTIN | INJECTABLE; INJECTION | 500MG | Yes | No |
Source provenance: Browse the complete Orange Book source catalog.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48776 | SUPPL | 2017-06-20 |
| 48755 | SUPPL | 2017-06-19 |
| 39238 | SUPPL | 2012-01-25 |
| 30431 | SUPPL | 2012-01-18 |
| 30430 | SUPPL | 2010-11-22 |
| 18163 | SUPPL | 2010-11-17 |
| 30429 | SUPPL | 2008-06-20 |
| 39237 | SUPPL | 2008-06-19 |
| 39236 | ORIG | 1999-09-21 |
| 8167 | ORIG | 1999-09-21 |