Home Applications 020120 Application 020120
Type NDA
Sponsor LUPIN ATLANTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALLERNAZE TRIAMCINOLONE ACETONIDE SPRAY, METERED;NASAL 0.05MG/SPRAY No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020120-001 ALLERNAZE TRIAMCINOLONE ACETONIDE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04
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 · 43 observed 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 2026-09-14 22:38:34 2026-08 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020120-001 ALLERNAZE 0.05MG/SPRAY SPRAY, METERED / NASAL 2000-02-04 f41ea6bd6efb…
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 10 of 11 · 208 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP 4aa792cc-7cd4-4a98-8730-fa36feaa9b7a 2023-02-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triasil TRIAMCINOLONE ACETONIDE PureTek Corporation dcf6c630-6f5d-3d2f-e053-2995a90ad812 2023-01-24 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE CMP Pharma, Inc. 5067e7da-3eed-4d6a-b870-47a35c3ded81 2023-01-17 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE KENALOG-40 TRIAMCINOLONE ACETONIDE Proficient Rx LP 1ed85825-cd03-4b5b-9c9a-946653b5f71a 2023-01-01 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE triamcinolone acetonide TRIAMCINOLONE ACETONIDE Padagis Israel Pharmaceuticals Ltd 3cb47c24-b7eb-4709-8a41-cbeceadbc8d9 2023-01-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Cosette Pharmaceuticals, Inc. b93b6763-446b-3277-497b-2ee50dcef80c 2022-11-30 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Cosette Pharmaceuticals, Inc. d2095a36-3fcf-7c20-95e5-e046b014565f 2022-11-29 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Cosette Pharmaceuticals, Inc. 5b3bcc75-608d-23fd-91a5-0806d5fe32f5 2022-11-18 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Signature Care Nasal Allergy TRIAMCINOLONE ACETONIDE Safeway 65761d58-312a-4ae9-b75b-2fe3fa5f7092 2022-11-15 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Nasal Allergy TRIAMCINOLONE ACETONIDE H E B faaa9219-2673-485e-bd84-71bdb23b3e47 2022-11-12 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP 5bb59e27-c49a-4543-bdca-c2070e90e162 2022-11-01 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Nasal Allergy TRIAMCINOLONE ACETONIDE CVS Pharmacy 8c236d9d-2dee-40fc-adac-9d17a5eace9e 2022-10-24 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Basic Care Nasal Allergy TRIAMCINOLONE ACETONIDE Amazon.com Services LLC a7bc5220-3a75-4bb7-a6a2-3a73fbd99d87 2022-10-13 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE DG Health Nasal Allergy TRIAMCINOLONE ACETONIDE Dolgencorp, LLC 6d326caa-40e7-4406-8768-f247f0777055 2022-10-13 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Equate Nasal Allergy TRIAMCINOLONE ACETONIDE Wal-Mart Stores Inc bdcbaba4-8f16-40ad-862f-9f0bc450ab87 2022-10-12 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP 7a2392c6-d26f-4def-8c7d-8b79e384c522 2022-10-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP b05fddfb-7d63-42d8-b41a-003492d3922c 2022-09-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP c91aaf91-afd9-4f0a-9634-6ed83763aa7c 2022-06-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triloan SUIK TRIAMCINOLONE ACETONIDE Asclemed USA, Inc. 320f7f0c-177c-42dc-96e6-4d688677c57a 2022-05-20 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Proficient Rx LP 63b51d50-7eb9-4687-965c-d4c57afc4030 2022-04-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 27437-143 AllerNaze Triamcinolone Acetonide Lupin Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 2032 SUPPL 2009-01-09 12227 SUPPL 2009-01-07 20476 ORIG 2002-11-20 12226 ORIG 2000-02-04 2031 ORIG 2000-02-04