Application 203443

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 55MG BASE	No	No
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	No	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	No	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	Approval date
A203443-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21
A203443-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22
A203443-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22

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 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203443-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203443-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203443-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203443-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203443-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203443-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203443-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203443-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203443-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203443-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203443-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203443-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203443-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203443-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203443-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203443-003	AB	1	`ea99ee380514…`

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 2 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	99825095-d897-4077-86df-483d505615b2	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	493bdeac-e073-4ec2-a481-85e6a6d3cb58	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	74946a91-b138-42cd-a9d4-58fe8f849270	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	653b22f3-9eb5-4c29-9b95-bc1c4f0273be	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	e1611d28-0c96-4ce2-ad5d-f62f66ec164d	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	bb3b9a7e-6724-4c2a-b3cb-236f522b31a8	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	c96b1c5d-7004-4ee2-ad48-0ba963389f86	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	REMEDYREPACK INC.	6597bdc9-9e3a-4c11-8b39-27b47f863287	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	0760232b-21a6-2b13-e063-6394a90a22c1	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	12559b29-6568-4b99-a16e-6a87038981f7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	f33fcfd2-b9ef-8e67-e053-2a95a90a0306	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Minocycline hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Ascend Laboratories, LLC	a8f95207-b259-4f50-87f2-3652d9268890	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6b2a7493-2e6c-4901-b697-17eb188cc8dd	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocin	MINOCYCLINE HYDROCHLORIDE	Melinta Therapeutics, LLC	e415c323-8219-464b-9e3e-72c5a796cdaa	2025-09-11	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	e69284bc-0479-48d0-beb5-a26cfad6cd76	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	2688e63a-09c7-4d73-a923-cf14fec7b1a4	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	ddd22f2c-050b-4776-912b-39b3e6202c75	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	American Health Packaging	94d941e3-d3d8-4414-bd5c-4a92848e738f	2025-07-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9f4139e4-d4ab-46ea-a3f1-f719ab57a55e	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	084fb405-fcb9-4db9-8d95-5a9c1d89f3b6	2025-07-03	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4293	Minocycline Hydrochloride	minocycline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4293	Minocycline Hydrochloride	minocycline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4294	Minocycline Hydrochloride	minocycline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4294	Minocycline Hydrochloride	minocycline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58817	ORIG	2019-05-21
32425	ORIG	2019-05-21