Application 050795
- Type
- NDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DORYX | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 75MG BASE | Yes | No |
| 002 | DORYX | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 100MG BASE | Yes | No |
| 003 | DORYX | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 150MG BASE | Yes | No |
| 004 | DORYX | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 80MG BASE | Yes | No |
| 005 | DORYX | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 200MG BASE | Yes | Yes |
| 006 | DORYX | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 50MG BASE | Yes | No |
| 007 | DORYX MPC | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 008 | DORYX MPC | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 120MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-557 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-557 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-557 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-557 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-557 | Doryx | doxycycline hyclate | Mayne Pharma | NDA | Current |
| 51862-558 | Doryx | doxycycline hyclate | Mayne Pharma | NDA | Current |
| 51862-558 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-558 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-558 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-558 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-559 | DORYX MPC | Doxycycline Hyclate | Mayne Pharma | NDA | Current |
| 51862-559 | DORYX MPC | Doxycycline Hyclate | Mayne Pharma | NDA | Current |
| 51862-559 | DORYX MPC | Doxycycline Hyclate | Mayne Pharma | NDA | Current |
| 51862-559 | DORYX MPC | Doxycycline Hyclate | Mayne Pharma | NDA | Current |
| 51862-559 | DORYX MPC | Doxycycline Hyclate | Mayne Pharma | NDA | Current |
| 51862-560 | DORYX MPC | doxycycline hyclate | Mayne Pharma | NDA | Current |
| 51862-562 | Doryx | doxycycline hyclate | Mayne Pharma | NDA | Current |
| 51862-562 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-562 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-562 | Doryx | doxycycline hyclate | Mayne Pharma Inc. | NDA | Current |
| 51862-571 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-571 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-571 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-571 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-709 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-709 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-709 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-709 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 51862-709 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma | NDA AUTHORIZED GENERIC | Current |
| 68308-710 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-710 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-710 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-710 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-715 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-715 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-715 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-715 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-716 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-716 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-716 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-716 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-775 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-775 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-775 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 68308-775 | Doxycycline Hyclate | Doxycycline Hyclate | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC | Current |
| 69597-345 | Doxycycline Hyclate | Doxycycline Hyclate | Basiem | NDA AUTHORIZED GENERIC | Current |
| 69597-345 | Doxycycline Hyclate | Doxycycline Hyclate | Basiem | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81856 | SUPPL | 2025-04-08 |
| 81786 | SUPPL | 2025-04-02 |
| 79887 | SUPPL | 2024-10-15 |
| 79882 | SUPPL | 2024-10-15 |
| 71632 | SUPPL | 2022-07-26 |
| 71631 | SUPPL | 2022-07-26 |
| 62194 | SUPPL | 2020-03-19 |
| 61884 | SUPPL | 2020-02-13 |
| 61879 | SUPPL | 2020-02-13 |
| 52510 | SUPPL | 2018-02-08 |
| 52505 | SUPPL | 2018-02-08 |
| 48641 | SUPPL | 2017-06-05 |
| 48619 | SUPPL | 2017-06-01 |
| 30579 | SUPPL | 2016-05-24 |
| 39354 | SUPPL | 2016-05-23 |
| 39353 | SUPPL | 2016-05-20 |
| 30578 | SUPPL | 2016-05-20 |
| 30576 | SUPPL | 2016-04-01 |
| 18273 | SUPPL | 2016-04-01 |
| 22244 | SUPPL | 2015-11-18 |
| 39352 | SUPPL | 2015-06-10 |
| 8307 | SUPPL | 2015-06-10 |
| 18274 | SUPPL | 2015-03-12 |
| 30577 | SUPPL | 2015-03-06 |
| 30575 | SUPPL | 2013-04-16 |
| 18270 | SUPPL | 2013-04-16 |
| 18272 | SUPPL | 2011-09-16 |
| 18271 | SUPPL | 2011-03-28 |
| 8306 | SUPPL | 2011-03-24 |
| 18269 | SUPPL | 2008-06-26 |
| 30574 | SUPPL | 2008-06-24 |
| 30573 | SUPPL | 2008-01-09 |
| 18268 | SUPPL | 2007-12-27 |
| 30572 | SUPPL | 2006-12-28 |
| 39351 | SUPPL | 2006-12-26 |
| 42742 | ORIG | 2006-04-21 |
| 39350 | ORIG | 2005-05-17 |
| 8305 | ORIG | 2005-05-17 |
| 53534 | SUPPL | 1900-01-01 |
| 52623 | SUPPL | 1900-01-01 |
| 52622 | SUPPL | 1900-01-01 |