Application 050451

Type: NDA
Sponsor: TRIAX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET;ORAL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050451-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1982-08-10
N050451-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1982-08-10

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	RLD	1982-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	RLD	1982-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050451-002	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	RLD	1982-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050451-003	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	RLD	1982-08-10	`4b0b4de00fa7…`

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 brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride 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 brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	4f904969-5af3-461e-b557-d03a1e5c7292	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d5fcba91-6aa6-4072-aea5-fb8da65d9aac	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	49e65b60-ffc9-4ccd-9aec-29a462358d27	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride 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 brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d67e4b17-7d44-4d72-9150-420d98cc6db3	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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