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 6 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	Redpharm Drug	1a3c713f-bc4f-4848-e063-6394a90a0272	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Redpharm Drug	0b251a58-30d8-dfec-e063-6294a90a3b45	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	direct rx	b56dffde-1334-f5a0-e053-2a95a90a717c	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	65b3a0e2-32a5-436a-b805-854fbffcb611	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	b4f2ab4f-c32b-6435-e053-2995a90a69b6	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	ecab47ea-d7b9-515d-e053-2995a90adc46	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	f5ed9293-15f8-ecfa-e053-2a95a90ab6a4	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Quality Care Products, LLC	2a3b79e8-f14c-4b44-9d3e-3c92a82269bd	2024-12-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Diirect_rx	1b403f4b-1c61-3991-e063-6394a90ae4f2	2024-12-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	fd58dbe5-aab2-4378-b054-d5c60d87074e	2024-10-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NCS HealthCare of KY, LLC dba Vangard Labs	104cac0f-7c99-4faf-ba08-0159ed767a3e	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	30b041a0-8f5f-4d9f-b11b-106f7432955b	2024-08-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Zydus Lifesciences Limited	68b3aba5-f1e4-4cdf-b244-0302aa8595fe	2024-08-16		Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Zydus Lifesciences Limited	fc8213e3-e546-495f-ac2c-3856db79c6e1	2024-08-16		Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	214e5a5c-7f3e-478b-93d3-1713de9e7672	2024-08-07	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a5f02688-cbba-4d9b-e053-2995a90ad1ba	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a707c9e3-00eb-e832-e053-2a95a90a5f58	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a2161675-505c-3d65-e053-2995a90aa644	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	860a1566-5857-ed88-e053-2991aa0ae2a4	2024-06-14	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