Application 050808

Type: NDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
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TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	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SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-05-08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SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-05-08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SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-05-08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SOLODYN	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2009-07-23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#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
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.

Product history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
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#

Patent history page 1 of 40 · 1,569 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050808-001	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-002	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-002	7541347	2027-04-02	U-917			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-002	7544373	2027-04-02		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-003	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-004	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-004	9192615	2031-11-17		Drug product	2016-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-005	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-005	9192615	2031-11-17		Drug product	2016-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-006	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-007	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050808-008	7919483	2027-03-07	U-1078			`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050808-001	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-002	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-002	7541347	2027-04-02	U-917			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-002	7544373	2027-04-02		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-003	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-004	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-004	9192615	2031-11-17		Drug product	2016-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-005	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-005	9192615	2031-11-17		Drug product	2016-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-006	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-007	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050808-008	7919483	2027-03-07	U-1078			`caaa826d4ba7…`
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…`

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.

Matched openFDA labels page 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arestin	MINOCYCLINE HYDROCHLORIDE	OraPharma, Inc.	8515df41-1936-4f3b-86ba-d2bb2a8441fb	2024-05-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	192327c5-d2bc-1bd1-e063-6394a90a110b	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	1229c84c-5627-4992-bb8a-7874b215c543	2023-09-17	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	4f904969-5af3-461e-b557-d03a1e5c7292	2023-05-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d5fcba91-6aa6-4072-aea5-fb8da65d9aac	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	49e65b60-ffc9-4ccd-9aec-29a462358d27	2022-05-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2022-03-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d67e4b17-7d44-4d72-9150-420d98cc6db3	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
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 table
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