Application 050808
- Type
- NDA
- Sponsor
- MEDICIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 65MG BASE | Yes | No |
| 005 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 115MG BASE | Yes | Yes |
| 006 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 105MG BASE | Yes | No |
| 007 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | Yes | No |
| 008 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 55MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050808-001 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | |
| N050808-002 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | |
| N050808-003 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | |
| N050808-004 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | |
| N050808-005 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | |
| N050808-006 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | |
| N050808-007 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | |
| N050808-008 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N050808-001 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-002 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-002 | 7541347 | 2027-04-02 | U-917 | ||
| N050808-002 | 7544373 | 2027-04-02 | Drug product | ||
| N050808-003 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-004 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | |
| N050808-005 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | |
| N050808-006 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-007 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-008 | 7919483 | 2027-03-07 | U-1078 |
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 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-004 | SOLODYN | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-005 | SOLODYN | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-006 | SOLODYN | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-007 | SOLODYN | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050808-008 | SOLODYN | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-004 | SOLODYN | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-005 | SOLODYN | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-006 | SOLODYN | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-007 | SOLODYN | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050808-008 | SOLODYN | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-006 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-007 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-008 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-007 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-008 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-008 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-008 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-007 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-008 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-007 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-008 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-007 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-008 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-006 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-007 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-008 | 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 | N050808-001 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | 7541347 | 2027-04-02 | U-917 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | 7544373 | 2027-04-02 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-003 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-004 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-005 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-006 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-007 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-008 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 8252776 | 2025-06-24 | U-124 | 2012-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 8268804 | 2025-06-24 | U-1078 | 2012-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 7919483 | 2027-03-07 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | 8252776 | 2025-06-24 | U-124 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | 8268804 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | 7919483 | 2027-03-07 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | 7541347 | 2027-04-02 | U-917 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | 7544373 | 2027-04-02 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-003 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-003 | 8252776 | 2025-06-24 | U-124 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-003 | 8268804 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-003 | 7919483 | 2027-03-07 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | 8252776 | 2025-06-24 | U-124 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | 8268804 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | 7919483 | 2027-03-07 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | 8252776 | 2025-06-24 | U-124 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | 8268804 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | 7919483 | 2027-03-07 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-006 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-006 | 8252776 | 2025-06-24 | U-124 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-006 | 8268804 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-006 | 8722650 | 2025-06-24 | U-1078 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3e74e8a3-2670-97f5-e063-6394a90a361e | 2026-08-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3e796794-b731-61d6-e063-6394a90aa9b3 | 2026-07-31 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Major Pharamceuticals | fd86ff45-37d0-4501-b9fb-e1836e4a8be4 | 2026-07-16 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | caa99901-467c-4e99-b7e9-fbabdf5d118c | 2026-07-08 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | REMEDYREPACK INC. | 0becbde8-6ec5-4830-a0d9-cfdb7b15eb84 | 2026-07-03 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 093ff3c7-3ecc-47b4-9ae6-5218bcd262b2 | 2026-06-26 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 65767ae3-b1ed-4492-90f2-703b2c7e0f38 | 2026-06-24 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 87a137c6-dd53-44d3-ab49-ef78ebed35c8 | 2026-06-12 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1ec20539-0421-4eac-95ed-e9acc6329fd0 | 2026-06-12 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7e2390b7-242c-43ff-afb3-b0a5e79351d3 | 2026-05-13 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | c11bfea8-6079-44ce-b8e1-20bfba631bec | 2026-05-04 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6e0efd1a-5a09-4030-8fe2-f98334cdeb0e | 2026-04-22 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 9c43389b-dc98-41f3-80bf-73d916ad6843 | 2026-04-22 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | A-S Medication Solutions | c7d0226e-5ac5-4fb1-9849-9d6663a2e8ad | 2026-04-17 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | bae17358-1180-4ca8-b163-f9a6f4f83a3d | 2026-04-09 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | 3539f84e-b489-4914-96c1-ac3731032971 | 2026-04-08 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | 55df55fb-18ec-4e00-9ed0-10bba0da513b | 2026-04-02 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 409dddb0-be3a-4ae3-ab39-88a6cd50a219 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | b3236a5c-8a5d-4d5d-9656-aee72a4c482b | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | a16012ce-5754-4177-bfb7-dcce696a7189 | 2026-03-25 | Warnings, Adverse reactions | MINOCYCLINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-9935 | minocycline hydrochloride | minocycline hydrochloride | Amneal Pharmaceuticals of New York, LLC | NDA AUTHORIZED GENERIC | Current |
| 0115-9935 | minocycline hydrochloride | minocycline hydrochloride | Amneal Pharmaceuticals of New York, LLC | NDA AUTHORIZED GENERIC | Current |
| 0115-9935 | minocycline hydrochloride | minocycline hydrochloride | Amneal Pharmaceuticals of New York, LLC | NDA AUTHORIZED GENERIC | Current |
| 0115-9935 | minocycline hydrochloride | minocycline hydrochloride | Impax Generics | NDA AUTHORIZED GENERIC | Current |
| 0115-9936 | minocycline hydrochloride | minocycline hydrochloride | Amneal Pharmaceuticals of New York, LLC | NDA AUTHORIZED GENERIC | Current |
| 0115-9936 | minocycline hydrochloride | minocycline hydrochloride | Amneal Pharmaceuticals of New York, LLC | NDA AUTHORIZED GENERIC | Current |
| 0115-9936 | minocycline hydrochloride | minocycline hydrochloride | Amneal Pharmaceuticals of New York, LLC | NDA AUTHORIZED GENERIC | Current |
| 0115-9936 | minocycline hydrochloride | minocycline hydrochloride | Impax Generics | NDA AUTHORIZED GENERIC | Current |
| 68682-466 | minocycline hydrochloride | minocycline hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-467 | minocycline hydrochloride | minocycline hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-468 | minocycline hydrochloride | minocycline hydrochloride | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 99207-463 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-463 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-463 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-463 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-464 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-464 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-464 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-464 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-465 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-465 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-465 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-465 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-466 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-466 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-466 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-466 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-467 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
| 99207-467 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-467 | Solodyn | minocycline hydrochloride | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-467 | Solodyn | minocycline hydrochloride | Bausch Health US LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81868 | SUPPL | 2025-04-08 |
| 81812 | SUPPL | 2025-04-02 |
| 81660 | SUPPL | 2025-03-20 |
| 81659 | SUPPL | 2025-03-20 |
| 81639 | SUPPL | 2025-03-19 |
| 81638 | SUPPL | 2025-03-19 |
| 30598 | SUPPL | 2013-10-22 |
| 39375 | SUPPL | 2013-10-21 |
| 22246 | SUPPL | 2012-03-27 |
| 30597 | SUPPL | 2011-04-21 |
| 8329 | SUPPL | 2011-03-25 |
| 18292 | SUPPL | 2011-03-18 |
| 39374 | SUPPL | 2010-12-16 |
| 18291 | SUPPL | 2010-01-12 |
| 30596 | SUPPL | 2010-01-05 |
| 8328 | SUPPL | 2009-07-31 |
| 18290 | SUPPL | 2009-07-30 |
| 22245 | ORIG | 2007-06-29 |
| 39373 | ORIG | 2006-05-16 |
| 30595 | ORIG | 2006-05-16 |