Application 204760

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOVANTIK	NALOXEGOL OXALATE	TABLET;ORAL	EQ 12.5MG BASE	Yes	No
002	MOVANTIK	NALOXEGOL OXALATE	TABLET;ORAL	EQ 25MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204760-001	MOVANTIK	NALOXEGOL OXALATE	EQ 12.5MG BASE	TABLET / ORAL		RLD	2014-09-16
N204760-002	MOVANTIK	NALOXEGOL OXALATE	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2014-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204760-001	7786133	2028-09-16	Drug substance, Drug product	2014-10-14
N204760-001	9012469	2032-04-02	Drug substance, Drug product	2015-05-15
N204760-002	7786133	2028-09-16	Drug substance, Drug product	2014-10-14
N204760-002	9012469	2032-04-02	Drug substance, Drug product	2015-05-15

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204760-001	MOVANTIK	EQ 12.5MG BASE	TABLET / ORAL	RLD	2014-09-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204760-002	MOVANTIK	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2014-09-16	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 376 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-001	7056500	2024-06-29	U-1185	Drug product	2015-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-001	8067431	2024-12-16	U-1185		2014-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-002	7056500	2024-06-29	U-1185	Drug product	2015-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-002	8067431	2024-12-16	U-1185		2014-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-001	7056500	2024-06-29	U-1185	Drug product	2015-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-001	8067431	2024-12-16	U-1185		2014-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-002	7056500	2024-06-29	U-1185	Drug product	2015-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-002	8067431	2024-12-16	U-1185		2014-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-002	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204760-002	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204760-001	7056500	2024-06-29	U-1185	Drug product	2015-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204760-001	8067431	2024-12-16	U-1185		2014-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204760-001	7786133	2028-09-16		Drug substance, Drug product	2014-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204760-001	9012469	2032-04-02		Drug substance, Drug product	2015-05-15	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204760-001	NCE	2019-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204760-002	NCE	2019-09-16	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N204760-001	NCE	2019-09-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204760-002	NCE	2019-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204760-001	NCE	2019-09-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204760-002	NCE	2019-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204760-001	NCE	2019-09-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204760-002	NCE	2019-09-16	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MOVANTIK	NALOXEGOL OXALATE	Valinor Pharma, LLC	28596788-b73f-4247-85fc-3105f51fff5a	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204760 application number: NDA204760
MOVANTIK	NALOXEGOL OXALATE	RedHill Biopharma Ltd	300a6474-ebcd-4404-8040-48fdcfcc1635	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204760 application number: NDA204760 ndc (product): 57841-1300 ndc (product): 57841-1301

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-1969	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1969	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1969	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1969	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1970	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1970	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1970	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1970	MOVANTIK	naloxegol oxalate	AstraZeneca Pharmaceuticals LP	NDA	Current
55700-383	MOVANTIK	naloxegol oxalate	Quality Care Products, LLC	NDA	Current
55700-383	MOVANTIK	naloxegol oxalate	Quality Care Products, LLC	NDA	Current
55700-383	MOVANTIK	naloxegol oxalate	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-988	MOVANTIK	naloxegol oxalate	Quality Care Products, LLC	NDA	Current
57841-1300	MOVANTIK	naloxegol oxalate	RedHill Biopharma Ltd	NDA	Current
57841-1300	MOVANTIK	naloxegol oxalate	RedHill Biopharma Ltd	NDA	Current
57841-1300	MOVANTIK	naloxegol oxalate	RedHill Biopharma Ltd	NDA	Current
57841-1301	MOVANTIK	naloxegol oxalate	RedHill Biopharma Ltd	NDA	Current
57841-1301	MOVANTIK	naloxegol oxalate	RedHill Biopharma Ltd	NDA	Current
57841-1301	MOVANTIK	naloxegol oxalate	RedHill Biopharma Ltd	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62573	SUPPL	2020-04-15
62555	SUPPL	2020-04-14
62554	SUPPL	2020-04-14
58945	SUPPL	2019-06-04
58890	SUPPL	2019-05-30
58889	SUPPL	2019-05-30
52799	SUPPL	2018-03-02
52798	SUPPL	2018-03-02
52783	SUPPL	2018-03-01
49223	SUPPL	2017-08-03
49212	SUPPL	2017-08-02
45113	SUPPL	2016-08-23
45112	SUPPL	2016-08-23
45159	SUPPL	2016-08-22
45158	SUPPL	2016-08-22
10388	SUPPL	2016-07-26
19593	SUPPL	2016-07-25
44908	ORIG	2014-10-17
43477	ORIG	2014-10-17
19592	ORIG	2014-09-19
10387	ORIG	2014-09-17