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 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
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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065281-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065281-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2005-12-21	`caaa826d4ba7…`
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…`

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 8 · 145 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 brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate 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 brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	df44c686-de34-487a-8741-a0a12993cab2	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate 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 brand name: DOXYCYCLINE HYCLATE 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 brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate 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 brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.