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 1 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	REMEDYREPACK INC.	051654c7-8ba6-44f2-842c-72f515e9b32d	2026-09-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9ecadbc8-3087-4692-916a-b7f392d8e8da	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	df44c686-de34-487a-8741-a0a12993cab2	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2c29f716-bdb0-437d-92a4-d856b87db976	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0106a3d3-db4d-f6ee-e063-6294a90a25e9	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	e7c14a8e-c713-4f03-94e8-1ec9ae077d4d	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	db53637e-16ac-41b0-b9d5-553471405d64	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	3af9348c-a98b-4059-a5ef-4229e2b33af0	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	1401d590-0967-4c6b-b52b-a83e9f6df097	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	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