Application 020784

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NASACORT HFA	TRIAMCINOLONE ACETONIDE	SPRAY, METERED;NASAL	0.055MG/SPRAY	No	No

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
N020784-001	NASACORT HFA	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED / NASAL			2004-04-07

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020784-001	NASACORT HFA	0.055MG/SPRAY	SPRAY, METERED / NASAL	2004-04-07	`3a93d1ddd44b…`

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 5 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	e7e16fc2-0222-44f5-925b-928d249f55cf	2025-10-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	f65c5847-365e-44b0-a756-1b16788684db	2025-10-09	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Xipere	TRIAMCINOLONE ACETONIDE	Bausch & Lomb Incorporated	ea6ad429-967f-4f75-a33d-e06f849bee80	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc	2548307e-8d36-4a63-862b-f2af7856104e	2025-10-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	b353c8b1-9088-4969-8199-37876f2461cc	2025-09-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	ProPharma Distribution	3edd3ad8-2561-59b5-e063-6294a90a0165	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Allegiant Health	1fd76a49-61ee-4d4d-8abc-e666b2d3c5b0	2025-07-29	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	d870041e-7c92-4f88-a305-ecb8f50a5773	2025-07-28	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	d086c38e-99c7-4d25-a722-a61c77d3989b	2025-07-28	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	4c6ff738-60a3-4339-8e94-26fb9df65841	2025-07-22	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	d0428b54-c4f5-46f1-a65e-7e20c56dbe78	2025-07-10	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Oralone	TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	ac1e2116-795e-4c20-974d-11fa07cf0fa7	2025-07-07	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	6b4a9a08-f436-4f33-a940-a97c727788f9	2025-07-03	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	5040eba2-2d00-496a-8773-66ba5440610f	2025-06-27	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	3597dccf-079c-5cd9-e063-6294a90aca71	2025-05-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	915b93be-425f-41b5-a9b0-5831b7e040a5	2025-05-16	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	da474ee7-ac67-4e62-991d-ca979f13dea2	2025-05-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Up and Up Nasal Allergy	TRIAMCINOLONE ACETONIDE	Target Corporation	492852c5-39eb-477f-9045-aaf50cf3306e	2025-04-29	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
NASACORT	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	37f290c9-576d-463f-b7d4-a146f53855b0	2025-04-23	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Eugia US LLC	d9abdda5-80e3-407c-b636-9cc5fc438098	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41699	ORIG	2007-07-03
25824	ORIG	2004-04-20