Application 050813

Type: NDA
Sponsor: PRAGMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOXATAG	AMOXICILLIN	TABLET, EXTENDED RELEASE;ORAL	775MG	Yes	No

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
N050813-001	MOXATAG	AMOXICILLIN	775MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-23

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N050813-001	8357394	2026-12-08		Drug product	2013-01-30
N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17
N050813-001	8299052	2027-05-07	U-1304		2012-12-03

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	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050813-001	MOXATAG	775MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-01-23	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050813-001	8778924	2026-12-08	U-897	Drug substance, Drug product	2015-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050813-001	8299052	2027-05-07	U-1304		2012-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050813-001	8357394	2026-12-08		Drug product	2013-01-30	`301d65b070ca…`

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 9 of 11 · 218 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	7524da98-b0a5-3db8-e053-2a91aa0a6ff1	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	234d0dfc-cb24-413f-b798-129c73eb848e	2024-06-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	7b182161-128e-430c-98b2-592c242ba711	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	260a3a79-9dd6-4c4b-82ec-f8050346e886	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	aee851cf-428e-4d29-a281-078fe00c56b0	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	9925773d-8ea1-4193-91e3-52cc1ce5ca67	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	14a5f8c2-fdaf-4ad4-982b-c5aa128e242d	2024-05-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	7db086c6-a56b-4848-9eec-abaaff9f5b6f	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	d5ecb620-5267-4dcf-be81-64c7766516f5	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	a2a5bb34-671b-499c-b8b4-c40fb51af09a	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	3d8a700b-b23b-459a-a19a-213dd39b6a3a	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	efc66d77-1733-41e1-9aed-7c10a4b4ba96	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	6a3d1af5-6e93-4f06-8d82-1c87290c46aa	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	322feb95-8bd4-440a-bda2-29ee19b11234	2024-04-15	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	4d0f063a-d896-4757-8f22-9614e2ad71d4	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	73219f24-6eac-4472-b2a7-cad36936c185	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	26202694-cf20-4b08-90cc-70a3d30cbb0f	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NorthStar Rx LLC	843f6053-63d9-47d2-81f1-b6aa78a7c20c	2024-03-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69442-030	MOXATAG	amoxicillin	Vernalis Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78380	SUPPL	2024-05-03
78356	SUPPL	2024-05-02
71098	SUPPL	2022-05-19
71092	SUPPL	2022-05-18
69822	SUPPL	2022-01-07
60809	SUPPL	2019-11-12
18294	SUPPL	2019-06-05
8334	SUPPL	2015-06-10
42751	ORIG	2010-03-26
24347	ORIG	2010-03-26
8333	ORIG	2008-01-25
39380	ORIG	2008-01-24
53173	ORIG	1900-01-01
53172	ORIG	1900-01-01
53171	ORIG	1900-01-01