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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	100b48e9-0884-4112-b9aa-cb6f07c28756	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	dddad9bc-a0a3-41bf-81e5-65d9903b14c6	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	fb4deae8-23f0-42dd-ac2e-b69ab39a6c4d	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a0f88292-680b-4d50-ae6e-0a7bccc3a9c6	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Chartwell RX, LLC	43fbe7ff-4b67-474d-bf27-e5710d8d10ac	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	8bf9cf23-8ffc-401f-981d-4878d694a468	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	85f082a5-bba1-4441-ba28-4b8ec9a537f2	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	2025-06-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ec93ad27-aff5-cbc7-e053-2a95a90adc7e	2025-05-07	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	25acb785-6838-4e62-9e86-ddc30b2b759a	2025-04-26	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	2025-04-11	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	9013ca48-15f2-43cd-a51d-91cf65c72a7c	2025-04-08	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	d00d9bc4-c764-4ec1-beb0-44668637bcfb	2025-01-28	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1c363cbb-099b-7c73-e063-6394a90ae13f	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	799a9871-3249-471e-b88d-5d8f7d4b96ad	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f901a1ba-1716-8795-e053-6294a90a4e77	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a6224eeb-25be-4f1d-889f-809aaf338c8c	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	26ee99af-f44b-4076-a08c-0a0dedc9edfe	2024-10-03		Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6f154720-706e-4177-8167-1bc893303f1b	2024-09-04	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	abaacdeb-2433-261a-e053-2995a90ae34e	2024-07-17	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