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 3 of 11 · 218 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Coupler LLC	5020950a-b248-a463-e063-6294a90ae57f	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	American Health Packaging	d339ea0f-8797-460f-a3b7-b8455c250366	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sportpharm LLC	9bb2856b-feef-4063-befc-2dd917502898	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	c19b533a-907a-6350-e053-2a95a90a1244	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	afef7c71-2d19-41ed-9213-b32ccc1bf1d3	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	4b23e6f5-9287-4c01-b795-b8c538833039	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c0e333d9-164d-4196-b5f5-929993d1c3c2	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Phamraceuticals Inc.	47424822-14a1-48e0-a62d-df34fe685726	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	8dfbaa75-87ba-4a6b-a2db-176441a842af	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	d6a33b28-f520-4a4c-b553-0ebd00558345	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	4fb7837e-964c-4d38-a3a5-b384b1bd6e08	2026-03-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	bd46de4c-4571-ba9a-e053-2a95a90a792d	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	f1eee459-9021-b26e-e053-2995a90a7291	2026-02-18	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	8bce45db-dea7-4090-9d64-8b11b08d963e	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	800f5fac-f2af-358f-e053-2a91aa0ad6a6	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Sportpharm LLC	d55dd9d9-e901-47b6-b496-5f2749726a2e	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	bb95fd06-f200-4de3-bfae-84d642d8e0f3	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	6a3f7e6c-fec2-41da-a070-00a02e64c920	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals, Inc.	88e76bdd-39f2-48c4-91ca-609511afd382	2026-01-26	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