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 7 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.	5c60cb1c-3baf-3af2-e053-2a91aa0ae208	2024-12-27	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	59a546ed-84b7-a54a-e053-2991aa0a3a0d	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	aaf42367-153e-4525-af5f-f5f1c7d6c559	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	bef50f2a-78c6-4d0c-8ad9-cfa3c801629d	2024-11-25	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	26469497-14c2-adb2-e063-6394a90af30a	2024-11-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	a56d7a5e-2b2c-4121-9d9c-a3283b3cebf9	2024-11-05	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	e13cafe2-f226-4021-81d8-7bd1f98b5582	2024-11-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	05e88717-2ce3-4b1a-88af-c3f61a2d8cd5	2024-11-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	0b5acc3f-c474-4b16-9d66-8048abb3b22d	2024-11-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	5edc5d32-43d5-4418-9832-40363a919edc	2024-11-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6	2024-11-04	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	963986fc-0e59-21b0-e053-2a95a90a9531	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	c3d3f94f-e976-4625-9667-3d716932f2fa	2024-10-09	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
AMOXICILLIN	AMOXICILLIN	Micro Labs Limited	42f935ca-45ba-4b3e-8b40-9b2d4eb56281	2024-10-03	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Proficient Rx LP	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	2024-10-01	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals Inc.	2177c68d-2884-ce70-e063-6294a90aa267	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	20eb4ade-f3b8-db66-e063-6294a90ae846	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	85721bc3-37eb-4db6-8a40-8a1412ac953a	2024-08-23	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	a18751fa-6202-4ae2-950a-a3f1dc9a8afd	2024-08-21	Warnings, Adverse reactions	Name fallback generic name: AMOXICILLIN
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	9cd42f6f-cc7a-43f5-98dd-a5d6210933ae	2024-08-14	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