Application 203634

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UCERIS	BUDESONIDE	TABLET, 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203634-001	UCERIS	BUDESONIDE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N203634-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203634-001	10307375	2031-09-07		Drug product	2019-06-14
N203634-001	10660858	2031-09-07		Drug product	2020-07-21
N203634-001	8895064	2031-09-07		Drug product	2014-11-25
N203634-001	9132093	2031-09-07		Drug product	2015-09-16
N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N203634-001	UCERIS	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-01-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N203634-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N203634-001	10307375	2031-09-07		Drug product	2019-06-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203634-001	10660858	2031-09-07		Drug product	2020-07-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203634-001	8895064	2031-09-07		Drug product	2014-11-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203634-001	9132093	2031-09-07		Drug product	2015-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N203634-001	9192581	2031-09-07	U-1325	Drug product	2015-12-03	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
budesonide	BUDESONIDE	Oceanside Pharmaceuticals	a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203634 application number: NDA203634 ndc (product): 68682-309
Uceris	BUDESONIDE	Santarus Inc.	92cbb190-8851-46ed-bfe0-166ca62ef2e9	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203634 application number: NDA203634 ndc (product): 68012-309

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68012-309	Uceris	budesonide	Santarus Inc.	NDA	Current
68012-309	Uceris	budesonide	Santarus Inc.	NDA	Current
68012-309	Uceris	budesonide	Santarus Inc.	NDA	Current
68012-309	Uceris	budesonide	Santarus Inc.	NDA	Current
68682-309	budesonide	budesonide	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-309	budesonide	budesonide	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-309	budesonide	budesonide	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78723	SUPPL	2024-07-02
78661	SUPPL	2024-06-06
62560	SUPPL	2020-04-14
62526	SUPPL	2020-04-10
45613	SUPPL	2016-10-17
45548	SUPPL	2016-10-17
24443	ORIG	2013-07-08
22930	ORIG	2013-07-08
32454	ORIG	2013-01-16
40317	ORIG	2013-01-15