Application 210296

Type: NDA
Sponsor: BANNER LIFE SCIENCES LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONOMETHYL FUMARATE	MONOMETHYL FUMARATE	CAPSULE, DELAYED RELEASE;ORAL	95MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N210296-001	BAFIERTAM	MONOMETHYL FUMARATE	95MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2020-04-28

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210296-001	10098863	2035-02-27	U-1384	Drug product	2020-05-21
N210296-001	10105335	2035-02-27		Drug product	2020-05-21
N210296-001	10105336	2035-02-27	U-1384	Drug product	2020-05-21
N210296-001	10105337	2035-02-27		Drug product	2020-05-21
N210296-001	10918615	2035-02-27	U-1384	Drug product	2021-02-19
N210296-001	10918616	2035-02-27	U-1384		2021-02-19
N210296-001	10918617	2035-02-27		Drug product	2021-02-19
N210296-001	10945985	2035-02-27		Drug product	2021-03-03
N210296-001	11590095	2035-02-27	U-1384		2023-03-30
N210296-001	11903918	2035-02-27	U-1384		2024-03-01
N210296-001	9326947	2035-02-27		Drug product	2020-05-21
N210296-001	9326965	2035-02-27	U-1384		2020-05-21
N210296-001	9511043	2035-02-27	U-1384		2020-05-21
N210296-001	9517209	2035-02-27		Drug product	2020-05-21
N210296-001	9566259	2035-02-27		Drug product	2020-05-21
N210296-001	9636318	2035-02-27	U-1384		2020-05-21
N210296-001	9636319	2035-02-27		Drug product	2020-05-21
N210296-001	9814691	2035-02-27	U-1384		2020-05-21
N210296-001	9814692	2035-02-27	U-1384		2020-05-21
N210296-001	9820960	2035-02-27		Drug product	2020-05-21
N210296-001	9820961	2035-02-27	U-1384	Drug product	2020-05-21

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 751 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210296-001	10098863	2035-02-27	U-1384	Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10105335	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10105336	2035-02-27	U-1384	Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10105337	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10918615	2035-02-27	U-1384	Drug product	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10918616	2035-02-27	U-1384		2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10918617	2035-02-27		Drug product	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10945985	2035-02-27		Drug product	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	11590095	2035-02-27	U-1384		2023-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	11903918	2035-02-27	U-1384		2024-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9326947	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9326965	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9511043	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9517209	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9566259	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9636318	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9636319	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9814691	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9814692	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9820960	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9820961	2035-02-27	U-1384	Drug product	2020-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10098863	2035-02-27	U-1384	Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10105335	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10105336	2035-02-27	U-1384	Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10105337	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10918615	2035-02-27	U-1384	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10918616	2035-02-27	U-1384		2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10918617	2035-02-27		Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10945985	2035-02-27		Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	11590095	2035-02-27	U-1384		2023-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	11903918	2035-02-27	U-1384		2024-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9326947	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9326965	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9511043	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9517209	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9566259	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9636318	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9636319	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9814691	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9814692	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BAFIERTAM	MONOMETHYL FUMARATE	Banner Life Sciences LLC	a161f9d4-70f1-4097-957a-eafb35d3274f	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210296 application number: NDA210296 ndc (product): 69387-001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69387-001	BAFIERTAM	monomethyl fumarate	Banner Life Sciences LLC	NDA	Current
69387-001	BAFIERTAM	monomethyl fumarate	Banner Life Sciences LLC	NDA	Current
69387-001	BAFIERTAM	monomethyl fumarate	Banner Life Sciences LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79757	SUPPL	2024-09-27
79753	SUPPL	2024-09-27
77099	SUPPL	2023-12-21
76833	SUPPL	2023-12-14
76800	SUPPL	2023-12-14
76799	SUPPL	2023-12-14
73159	SUPPL	2023-01-13
73151	SUPPL	2023-01-13
65392	ORIG	2020-11-30
62736	ORIG	2020-04-29
56522	ORIG	2020-04-29