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| TABLET, DELAYED RELEASE;ORAL | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050795-001 | DORYX | DOXYCYCLINE HYCLATE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | |
| N050795-002 | DORYX | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | |
| N050795-003 | DORYX | DOXYCYCLINE HYCLATE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | |
| N050795-004 | DORYX | DOXYCYCLINE HYCLATE | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | |
| N050795-005 | DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | |
| N050795-006 | DORYX | DOXYCYCLINE HYCLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | |
| N050795-007 | DORYX MPC | DOXYCYCLINE HYCLATE | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | |
| N050795-008 | DORYX MPC | DOXYCYCLINE HYCLATE | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | |
| N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | |
| N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | |
| N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 |
| N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | |
| N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 |
| N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | |
| N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 |
| N050795-008 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | |
| N050795-008 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-001 | DORYX | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-002 | DORYX | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2005-05-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-003 | DORYX | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2008-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-004 | DORYX | EQ 80MG BASE | TABLET, DELAYED RELEASE / ORAL | RLD | 2013-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-005 | DORYX | EQ 200MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2013-04-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-006 | DORYX | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2014-12-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-007 | DORYX MPC | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-008 | DORYX MPC | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2016-05-20 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050795-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050795-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050795-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050795-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050795-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050795-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050795-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050795-005 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050795-005 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050795-005 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050795-005 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050795-005 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050795-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050795-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050795-006 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050795-006 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050795-006 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050795-001 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050795-008 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050795-008 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-001 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-002 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-003 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-004 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-005 | 8715724 | 2028-02-03 | Drug product | 2014-05-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-006 | 8715724 | 2028-02-03 | Drug product | 2015-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 9511031 | 2034-10-23 | Drug product | 2017-01-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-007 | 9446057 | 2034-12-23 | U-918 | Drug product | 2016-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-008 | 8715724 | 2028-02-03 | Drug product | 2016-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050795-008 | 9295652 | 2034-10-23 | U-918 | Drug product | 2016-05-23 | 6a471c1ec25d… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DORYX MPC | DOXYCYCLINE HYCLATE | Mayne Pharma Commercial LLC | f9277bb8-982d-444d-9325-35d5c53a2d35 | 2026-02-16 | Warnings, Adverse reactions | 050795 NDA050795 51862-560 51862-559 |
| Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Mayne Pharma Commercial LLC | cd2ab9b8-9619-4199-8a5d-83377b3274d1 | 2025-04-14 | Warnings, Adverse reactions | 050795 NDA050795 68308-710 68308-716 68308-715 68308-775 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-557 | Doryx | doxycycline hyclate | Mayne Pharma | 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 Inc. | 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 |