Application 211929

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORTIKOS	BUDESONIDE	CAPSULE, EXTENDED RELEASE;ORAL	6MG	Yes	No
002	ORTIKOS	BUDESONIDE	CAPSULE, EXTENDED RELEASE;ORAL	9MG	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
N211929-001	ORTIKOS	BUDESONIDE	6MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2019-06-13
N211929-002	ORTIKOS	BUDESONIDE	9MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2019-06-13

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211929-001	10172802	2036-09-09	U-2554		2019-06-28
N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28
N211929-002	10172802	2036-09-09	U-2554		2019-06-28
N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28

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	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211929-001	ORTIKOS	6MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211929-002	ORTIKOS	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2019-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211929-001	ORTIKOS	6MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211929-002	ORTIKOS	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2019-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211929-001	ORTIKOS	6MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211929-002	ORTIKOS	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2019-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211929-001	ORTIKOS	6MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211929-002	ORTIKOS	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2019-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211929-001	ORTIKOS	6MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211929-002	ORTIKOS	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2019-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211929-001	ORTIKOS	6MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2019-06-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211929-002	ORTIKOS	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2019-06-13	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 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	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`d06236e962d9…`

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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Rising Pharma Holdings, Inc.	3235e2a4-8e12-2d58-e063-6294a90a4936	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide Inhalation Suspension	BUDESONIDE	Cipla USA Inc.	c52c5382-1400-44b9-95be-a30e1cf706da	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	REMEDYREPACK INC.	5e39c491-2793-410e-b77f-8b3cbe9b6231	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	American Health Packaging	c7df2a10-4166-423e-bb60-5f3a8234f26c	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Cardinal Health 107, LLC	3e8a6cf4-4bda-4e22-8653-12635adfb316	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Sun Pharmaceutical Industries, Inc.	a39fbcfc-3ffd-44bd-b882-01f8e1844213	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide Inhalation	BUDESONIDE	Preferred Pharmaceuticals Inc.	1d139a25-9c17-4b3e-8ffd-b2d562cc00ee	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	American Health Packaging	4a8e79df-3946-4e9a-b214-e9fdd824b565	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Rugby Laboratories	04eb9e98-1323-353f-3fd7-2d317dfac526	2026-02-27	Warnings	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Bryant Ranch Prepack	33def4dc-b469-f987-e063-6294a90ace0b	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide Inhalation	BUDESONIDE	Amneal Pharmaceuticals of New York LLC	e8ef9489-83a2-4817-b21c-ea3fecd8c8dd	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Tarpeyo	BUDESONIDE	Calliditas Therapeutics AB	938cada4-d6bf-4252-836f-dd40f9eadb4d	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Walgreens	9d519bf3-8d9b-5208-13c5-308edc24aca7	2026-01-21	Warnings	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	CVS Pharmacy	b2650d29-c011-48f1-a7f4-040011d4563d	2026-01-21	Warnings	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Golden State Medical Supply, Inc.	263303c2-8e4f-7b6c-e063-6394a90aef9e	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Rugby Laboratories	b83af99e-1619-48ed-a033-e5207033f77e	2025-12-09	Warnings	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Apotex Corp.	f1aac35a-bc72-dd68-8179-8661354589cb	2025-09-22	Warnings	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	Rubicon Holdings Inc.	ae1105cd-69fc-4c15-937f-c535304341c2	2025-09-04	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Amneal Pharmaceuticals of New York LLC	10336e42-0e9d-45c4-80bc-5149d5ec9e1c	2025-06-19	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55566-1002	Budesonide	Budesonide	FERRING PHARMACEUTICALS INC.	NDA	Current
55566-1002	Ortikos	Budesonide	Ferring Pharmaceuticals Inc.	NDA	Current
55566-1002	Ortikos	Budesonide	Ferring Pharmaceuticals Inc.	NDA	Current
55566-1002	Ortikos	Budesonide	Ferring Pharmaceuticals Inc.	NDA	Current
55566-1020	Budesonide	Budesonide	FERRING PHARMACEUTICALS INC.	NDA	Current
55566-1020	Ortikos	Budesonide	Ferring Pharmaceuticals Inc.	NDA	Current
55566-1020	Ortikos	Budesonide	Ferring Pharmaceuticals Inc.	NDA	Current
55566-1020	Ortikos	Budesonide	Ferring Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78728	SUPPL	2024-07-02
78662	SUPPL	2024-06-06
61639	ORIG	2020-01-24
59092	ORIG	2019-06-17
59069	ORIG	2019-06-14