Application 209269

Type: NDA
Sponsor: EPI HLTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOLIRA	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	No	No
002	MINOLIRA	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209269-001	MINOLIRA	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL			2017-05-08
N209269-002	MINOLIRA	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL			2017-05-08

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209269-001	11103517	2036-04-07		Drug product	2021-09-02
N209269-002	11103517	2036-04-07		Drug product	2021-09-02

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`bb7c543d1eb4…`

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-539	Minolira	Minolira	Dr. Reddys Laboratories Inc	NDA	Current
43598-540	Minolira	Minolira	Dr. Reddys Laboratories Inc	NDA	Current
71403-101	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-101	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-101	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-101	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-102	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-102	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-102	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current
71403-102	Minolira Extended Release	Minocycline Hydrochloride	EPI Health, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54737	ORIG	2018-07-02