Application 202292

Type: NDA
Sponsor: NAPO PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYTESI	CROFELEMER	TABLET, DELAYED RELEASE;ORAL	125MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N202292-001	MYTESI	CROFELEMER	125MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2012-12-31

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202292-001	8962680	2031-10-31	U-1319		2015-02-24
N202292-001	9585868	2031-10-31	U-1319		2017-07-24

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202292-001	MYTESI	125MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2012-12-31	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 2 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N202292-001	7341744	2022-06-02	U-1319	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202292-001	7341744	2022-06-02	U-1319	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202292-001	7341744	2022-06-02	U-1319	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202292-001	7341744	2022-06-02	U-1319	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202292-001	7341744	2022-06-02	U-1319	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202292-001	7341744	2022-06-02	U-1319	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202292-001	7341744	2022-06-02	U-1319	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202292-001	7341744	2022-06-02	U-1319	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202292-001	7341744	2022-06-02	U-1319	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202292-001	7341744	2022-06-02	U-1319	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202292-001	7341744	2022-06-02	U-1319	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202292-001	9585868	2031-10-31	U-1319		2017-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202292-001	8962680	2031-10-31	U-1319		2015-02-24	`a72a2bbeb626…`

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
MYTESI	CROFELEMER	Napo Pharmaceuticals, Inc.	45584fba-8081-4cd1-a21e-3ea8237f62ff	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202292 application number: NDA202292 ndc (product): 70564-802

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70564-802	MYTESI	Crofelemer	Napo Pharmaceuticals, Inc.	NDA	Current
70564-802	MYTESI	Crofelemer	Napo Pharmaceuticals, Inc.	NDA	Current
70564-802	MYTESI	Crofelemer	Napo Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78071	SUPPL	2024-04-04
78061	SUPPL	2024-04-04
65252	SUPPL	2020-11-17
65248	SUPPL	2020-11-16
52910	SUPPL	2018-03-12
52876	SUPPL	2018-03-08
44851	ORIG	2013-02-19
43394	ORIG	2013-02-19
32228	ORIG	2013-01-02
19313	ORIG	2012-12-31