Application 050582

Type: NDA
Sponsor: MAYNE PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DORYX	DOXYCYCLINE HYCLATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 100MG BASE	Yes	No
002	DORYX	DOXYCYCLINE HYCLATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 75MG BASE	Yes	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
N050582-001	DORYX	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD	1985-07-22
N050582-002	DORYX	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD	2001-08-13

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	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050582-001	DORYX	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	1985-07-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050582-002	DORYX	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD	2001-08-13	`74a2ff9319b5…`

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 5 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	6772807d-a39e-47ce-9584-a08e7f8940d2	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	bed39bae-64c2-44b4-9c95-682ead4e6738	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	a5571acf-3284-4559-8cc0-b4856ac6d94d	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	7c33c1b8-100e-4df8-be8d-de3eed7ced94	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	cec4368f-2852-443d-9d6f-7ba95807021b	2025-04-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	b3294889-e8f8-42f1-9bd0-13d87572997a	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	65cac0b6-3550-48cf-bffa-cf42443c2731	2025-04-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	cd2ab9b8-9619-4199-8a5d-83377b3274d1	2025-04-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	325d5331-d48e-1bc4-e063-6394a90a65b9	2025-04-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	bff3f426-44fc-4dbf-96df-df44011103e8	2025-04-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Epic Pharma, LLC	2b402587-8ecc-4fea-83ad-8071345b6356	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	c2b08332-3256-4658-965a-ede3d973a388	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	e726157e-ce44-4df3-8161-7016700dd751	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	EPIC PHARMA, LLC	b3cd7b44-db40-4ce5-895e-d4c85a0068ae	2025-03-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	861b71f3-37e8-4596-838c-c8dad8ed5ff4	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	942ab6dd-e355-41da-b139-72cc8b7a2667	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	5b4390ed-a0ec-4ef8-864c-8a33a83653f9	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug, Inc.	09d19663-a8b9-0c3f-e063-6394a90aa446	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE

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
81851	SUPPL	2025-04-08
81806	SUPPL	2025-04-02
62032	SUPPL	2020-03-04
62024	SUPPL	2020-03-04
52511	SUPPL	2018-02-08
52506	SUPPL	2018-02-08
39002	SUPPL	2015-09-04
30112	SUPPL	2015-09-04
30111	SUPPL	2011-03-24
39001	SUPPL	2008-02-14
7844	SUPPL	2008-02-13
39000	SUPPL	2005-05-17
7843	SUPPL	2005-05-17
30110	SUPPL	2004-02-27
30109	SUPPL	2003-06-08
7842	SUPPL	2002-06-18