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 43.

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 · 86 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	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211929-001	ORTIKOS	6MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211929-002	ORTIKOS	9MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2019-06-13	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 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	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211929-001	10172802	2036-09-09	U-2554		2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211929-001	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211929-002	10172802	2036-09-09	U-2554		2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211929-002	9707182	2036-09-09	U-2554	Drug product	2019-06-28	`caaa826d4ba7…`
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…`

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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	A-S Medication Solutions	32e30f11-e19b-4e23-a893-92d95e48edef	2023-11-29	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	10ea5d87-6ed0-4fa5-a37b-2043c8560bc0	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	A-S Medication Solutions	4a7d97e0-36f7-4ac9-8f9b-4c3aac568c2b	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
BUDESONIDE	BUDESONIDE	Padagis Israel Pharmaceuticals Ltd	ad4a68e7-9200-4f05-8058-714d5d8900f8	2023-04-17	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	79fc8cf4-bb33-4892-9dd2-641d7e943a01	2023-02-04	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	b2cf85c5-3ae0-4f91-9f3a-1d6771e14a73	2021-10-01	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	4f126a29-38f7-4c4c-8978-37e72b289902	2021-01-12	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	2414058b-5d39-42f2-915f-03a5e1101ab5	2021-01-12	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide Inhalation Suspension	BUDESONIDE	Exelan Pharmaceuticals, Inc.	d9656442-4587-4867-9a8c-5f5b0402936e	2020-12-11	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Uceris	BUDESONIDE	Salix Pharmaceuticals, Inc.	230e4596-2a9b-4d55-b0a0-0cabbcff5289	2020-04-23	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
Budesonide	BUDESONIDE	Teva Pharmaceuticals USA, Inc.	d90ffda1-12c7-4726-90e9-64bb103e84b5	2019-10-31	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE
PULMICORT RESPULES	BUDESONIDE	AstraZeneca Pharmaceuticals LP	33cd9834-76df-4f26-3fa2-aab6b9eee8f2	2019-10-11	Warnings, Adverse reactions	Name fallback generic name: BUDESONIDE

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 · 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