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 7 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	NuCare Pharmaceuticals,Inc.	88012cf8-509b-84cf-e053-2a95a90af3bc	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a2df1a8c-7a22-462d-830a-04e6ac5a912f	2024-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	2024-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	2024-04-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a84d7562-08bf-417f-a599-ba0d17c55232	2024-04-25	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Proficient Rx LP	e38f3cd2-47e5-438f-bbe3-50b578360f74	2024-03-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Lupin Pharmaceuticals,Inc.	b752ea66-3144-4f78-96fe-a5f4d92740a7	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0fdc3d87-8819-4c2c-e063-6394a90a687b	2024-01-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	e567b431-53fe-4e27-9b05-bf6eeb8abb51	2023-12-11	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2023-04-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	6e587d8d-1a82-4dfa-acea-88704d408f2f	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	24c8472a-dd07-4f84-8bea-20a3f178d119	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	ec4535a1-69f0-40a2-bcba-11afc75c721d	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	dd7672c9-b10f-4ea1-9000-ef3e3faa10db	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	86c1f165-af79-4f01-ab61-3bdbce24cd0d	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	2993ac3d-0ec4-4230-858e-9fd00063cf57	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	3303b423-b270-495b-9360-e43144fcf6f2	2021-04-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sonoma Pharmaceuticals, Inc.	4fa26176-a730-48ed-9659-e2f64212f418	2018-05-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Novel Laboratories, Inc.	25a92544-1421-4ccb-a49c-11742851f214	2018-03-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Acticlate CAP	DOXYCYCLINE HYCLATE	Aqua Pharmaceuticals	5e96d473-63dd-4446-88cf-eef2cd3339f0	2017-11-28	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