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 1.

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 · 122 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203443-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203443-003	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203443-001	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-08-21	`8072bd15b7f6…`

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 1 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	PD-Rx Pharmaceuticals, Inc.	3e74e8a3-2670-97f5-e063-6394a90a361e	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3e796794-b731-61d6-e063-6394a90aa9b3	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Major Pharamceuticals	fd86ff45-37d0-4501-b9fb-e1836e4a8be4	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	caa99901-467c-4e99-b7e9-fbabdf5d118c	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	REMEDYREPACK INC.	0becbde8-6ec5-4830-a0d9-cfdb7b15eb84	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	093ff3c7-3ecc-47b4-9ae6-5218bcd262b2	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	65767ae3-b1ed-4492-90f2-703b2c7e0f38	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	87a137c6-dd53-44d3-ab49-ef78ebed35c8	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ec20539-0421-4eac-95ed-e9acc6329fd0	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7e2390b7-242c-43ff-afb3-b0a5e79351d3	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	c11bfea8-6079-44ce-b8e1-20bfba631bec	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6e0efd1a-5a09-4030-8fe2-f98334cdeb0e	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9c43389b-dc98-41f3-80bf-73d916ad6843	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	c7d0226e-5ac5-4fb1-9849-9d6663a2e8ad	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	bae17358-1180-4ca8-b163-f9a6f4f83a3d	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: MINOCYCLINE HYDROCHLORIDE generic name: MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	3539f84e-b489-4914-96c1-ac3731032971	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: MINOCYCLINE HYDROCHLORIDE generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	55df55fb-18ec-4e00-9ed0-10bba0da513b	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	409dddb0-be3a-4ae3-ab39-88a6cd50a219	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	b3236a5c-8a5d-4d5d-9656-aee72a4c482b	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a16012ce-5754-4177-bfb7-dcce696a7189	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE

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