Application 050751

Type: NDA
Sponsor: TOLMAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATRIDOX	DOXYCYCLINE HYCLATE	SYSTEM, EXTENDED RELEASE;PERIODONTAL	50MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050751-001	ATRIDOX	DOXYCYCLINE HYCLATE	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL		RLD	1998-09-03

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 2 · 43 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	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD, RS	1998-09-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050751-001	ATRIDOX	50MG	SYSTEM, EXTENDED RELEASE / PERIODONTAL	RLD	1998-09-03	`f41ea6bd6efb…`

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 5 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	A-S Medication Solutions	6772807d-a39e-47ce-9584-a08e7f8940d2	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	bed39bae-64c2-44b4-9c95-682ead4e6738	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	a5571acf-3284-4559-8cc0-b4856ac6d94d	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	7c33c1b8-100e-4df8-be8d-de3eed7ced94	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	cec4368f-2852-443d-9d6f-7ba95807021b	2025-04-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	b3294889-e8f8-42f1-9bd0-13d87572997a	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	65cac0b6-3550-48cf-bffa-cf42443c2731	2025-04-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	cd2ab9b8-9619-4199-8a5d-83377b3274d1	2025-04-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	325d5331-d48e-1bc4-e063-6394a90a65b9	2025-04-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	bff3f426-44fc-4dbf-96df-df44011103e8	2025-04-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Epic Pharma, LLC	2b402587-8ecc-4fea-83ad-8071345b6356	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	c2b08332-3256-4658-965a-ede3d973a388	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	e726157e-ce44-4df3-8161-7016700dd751	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	EPIC PHARMA, LLC	b3cd7b44-db40-4ce5-895e-d4c85a0068ae	2025-03-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	861b71f3-37e8-4596-838c-c8dad8ed5ff4	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	942ab6dd-e355-41da-b139-72cc8b7a2667	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	5b4390ed-a0ec-4ef8-864c-8a33a83653f9	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug, Inc.	09d19663-a8b9-0c3f-e063-6394a90aa446	2025-01-23	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59883-100	ATRIDOX	Doxycycline Hyclate	Den-Mat Holdings, LLC	NDA	Current
59883-100	ATRIDOX	Doxycycline Hyclate	Den-Mat Holdings, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30447	SUPPL	2011-02-23
39253	SUPPL	2011-02-14
8185	SUPPL	2009-06-10
42715	ORIG	2004-05-27
18177	SUPPL	2003-07-08
8184	SUPPL	2003-07-06
30446	SUPPL	2003-03-26
18176	SUPPL	2003-03-26
18175	ORIG	1998-09-04
8183	ORIG	1998-09-04