Application 050445

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCIN	MINOCYCLINE HYDROCHLORIDE	SUSPENSION;ORAL	EQ 50MG BASE/5ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050445-001	MINOCIN	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE/5ML	SUSPENSION / ORAL		Approved before 1982

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050445-001	MINOCIN	EQ 50MG BASE/5ML	SUSPENSION / ORAL	Approved before 1982	`f41ea6bd6efb…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81850	SUPPL	2025-04-08
81807	SUPPL	2025-04-02
79145	SUPPL	2024-07-22
79131	SUPPL	2024-07-22
56525	SUPPL	2018-11-20
56511	SUPPL	2018-11-20
38943	SUPPL	2015-03-02
30035	SUPPL	2015-02-27
17836	SUPPL	2010-09-20
7758	SUPPL	2010-09-16
38942	SUPPL	2007-01-18
30034	SUPPL	2007-01-18
30033	SUPPL	2005-10-20
17835	SUPPL	2005-09-30
30031	SUPPL	2005-02-17
42643	SUPPL	2004-06-29
30032	SUPPL	2004-06-01
7757	SUPPL	2004-06-01
7756	SUPPL	2002-05-31
30030	SUPPL	2002-02-01
30029	SUPPL	2002-02-01
7755	SUPPL	2002-02-01
7754	SUPPL	2002-02-01