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 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.

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