Application 065281

Type: ANDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 75MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065281-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2005-12-21
A065281-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2005-12-21

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`782e0a99824c…`

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 2 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	5f523294-e62b-4da5-8799-047d4bed966f	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	52ba329a-8cb3-cf30-e063-6394a90aa0dc	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	3ae4ca12-be39-46b9-bc4c-f8356776c175	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	a34fbbc7-09dc-42d6-a075-f4ea8f170ba7	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	7a915c50-6fce-45e6-9554-677bb09a868d	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Cranbury Pharmaceuticals, LLC	fe6985d2-37f7-4277-94a9-f7125b4b3fd7	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Direct_Rx	2ad2b85f-2479-c7cd-e063-6294a90acca1	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	9798c4de-8af7-41c4-acc2-1e9775194297	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	0aaa4ff7-7fba-4a40-9b49-82e4da68a48f	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	10988250-b267-4f10-b264-5f127cc1ae18	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DORYX MPC	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	f9277bb8-982d-444d-9325-35d5c53a2d35	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	bea36ec9-f7fd-4295-bfbd-0228cffcddd7	2026-02-08	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	45c4b584-b7e2-4e91-a93d-aff14feb606f	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	50617adc-8528-414d-bb6c-78887d404983	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6e06e73c-b777-4a2d-988f-b009f2fc34d1	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE

Application 065281

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#