Application 050649

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCIN	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	Yes	No
002	MINOCIN	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG BASE	Yes	No
003	MINOCIN	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050649-001	MINOCIN	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31
N050649-002	MINOCIN	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31
N050649-003	MINOCIN	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050649-001	AB
N050649-002	AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050649-002	MINOCIN	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050649-003	MINOCIN	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2001-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050649-001	MINOCIN	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1990-05-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050649-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050649-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050649-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050649-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050649-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050649-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050649-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050649-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050649-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050649-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050649-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050649-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050649-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050649-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050649-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050649-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050649-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050649-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050649-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050649-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050649-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050649-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050649-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050649-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050649-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050649-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050649-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050649-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050649-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050649-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050649-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050649-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050649-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050649-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050649-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050649-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050649-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050649-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050649-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050649-002	AB	1	`74a2ff9319b5…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16781-400	Minocin	minocycline hydrochloride	Onset Dermatologics LLC	NDA	Current
16781-400	Minocin	minocycline hydrochloride	Bausch Health US, LLC	NDA	Current
16781-403	Minocin	minocycline hydrochloride	Onset Dermatologics LLC	NDA	Current
16781-403	Minocin	minocycline hydrochloride	Bausch Health US, LLC	NDA	Current
43353-172	Minocin	minocycline hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81853	SUPPL	2025-04-08
81793	SUPPL	2025-04-02
79144	SUPPL	2024-07-22
79129	SUPPL	2024-07-22
49037	SUPPL	2017-07-21
49025	SUPPL	2017-07-20
46175	SUPPL	2016-12-15
46189	SUPPL	2016-12-14
39073	SUPPL	2015-03-26
30224	SUPPL	2015-03-11
17973	SUPPL	2010-09-20
30223	SUPPL	2010-09-17
7935	SUPPL	2008-07-01
39072	SUPPL	2008-06-30
30222	SUPPL	2007-06-04
7933	SUPPL	2007-04-09
17972	SUPPL	2007-04-06
7934	SUPPL	2007-02-02
39071	SUPPL	2007-01-25
7932	SUPPL	2005-10-20
30220	SUPPL	2005-02-17
42664	SUPPL	2004-06-29
30221	SUPPL	2004-06-01
7931	SUPPL	2004-06-01
7930	SUPPL	2002-05-31
7929	SUPPL	2002-02-01
7928	SUPPL	2002-02-01