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 7 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	NuCare Pharmaceuticals,Inc.	88012cf8-509b-84cf-e053-2a95a90af3bc	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a2df1a8c-7a22-462d-830a-04e6ac5a912f	2024-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	2024-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	2024-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a84d7562-08bf-417f-a599-ba0d17c55232	2024-04-25	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Proficient Rx LP	e38f3cd2-47e5-438f-bbe3-50b578360f74	2024-03-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Lupin Pharmaceuticals,Inc.	b752ea66-3144-4f78-96fe-a5f4d92740a7	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0fdc3d87-8819-4c2c-e063-6394a90a687b	2024-01-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	e567b431-53fe-4e27-9b05-bf6eeb8abb51	2023-12-11	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2023-04-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	6e587d8d-1a82-4dfa-acea-88704d408f2f	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	24c8472a-dd07-4f84-8bea-20a3f178d119	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	ec4535a1-69f0-40a2-bcba-11afc75c721d	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	dd7672c9-b10f-4ea1-9000-ef3e3faa10db	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	86c1f165-af79-4f01-ab61-3bdbce24cd0d	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	2993ac3d-0ec4-4230-858e-9fd00063cf57	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	3303b423-b270-495b-9360-e43144fcf6f2	2021-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sonoma Pharmaceuticals, Inc.	4fa26176-a730-48ed-9659-e2f64212f418	2018-05-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Novel Laboratories, Inc.	25a92544-1421-4ccb-a49c-11742851f214	2018-03-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Acticlate CAP	DOXYCYCLINE HYCLATE	Aqua Pharmaceuticals	5e96d473-63dd-4446-88cf-eef2cd3339f0	2017-11-28	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