Application 050582
- Type
- NDA
- Sponsor
- MAYNE PHARMA INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DORYX | DOXYCYCLINE HYCLATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 100MG BASE | Yes | No |
| 002 | DORYX | DOXYCYCLINE HYCLATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 75MG BASE | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81851 | SUPPL | 2025-04-08 |
| 81806 | SUPPL | 2025-04-02 |
| 62032 | SUPPL | 2020-03-04 |
| 62024 | SUPPL | 2020-03-04 |
| 52511 | SUPPL | 2018-02-08 |
| 52506 | SUPPL | 2018-02-08 |
| 39002 | SUPPL | 2015-09-04 |
| 30112 | SUPPL | 2015-09-04 |
| 30111 | SUPPL | 2011-03-24 |
| 39001 | SUPPL | 2008-02-14 |
| 7844 | SUPPL | 2008-02-13 |
| 39000 | SUPPL | 2005-05-17 |
| 7843 | SUPPL | 2005-05-17 |
| 30110 | SUPPL | 2004-02-27 |
| 30109 | SUPPL | 2003-06-08 |
| 7842 | SUPPL | 2002-06-18 |