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 7 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 TruPharma, LLC 888f2b6f-1d11-4774-9eab-714af40edb7d 2024-12-23 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals,Inc. a4d74513-0548-4f11-e053-2995a90a1830 2024-12-13 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Mylan Institutional LLC 4015ad7d-46bf-454e-ac86-91fa5dd6a07b 2024-12-05 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Cosette Pharmaceuticals, Inc. 5397395a-2d13-9311-7cb2-c316339d4acc 2024-12-04 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE nasal allergy TRIAMCINOLONE ACETONIDE Kroger Company b5f3bb98-4eb5-4c25-ae90-e2aa9ff5667d 2024-11-27 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack c29de67c-c4c7-412b-ae5f-b5562a95a8f9 2024-11-20 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack c2b12aa8-1875-489b-8d16-fb588ad3cf54 2024-11-20 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Saptalis Pharmaceuticals, LLC. a77a31dd-048e-4a4d-b006-6913978d7438 2024-11-13 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack a7c85d92-734e-4175-b1a7-eaff97abc45c 2024-11-12 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Proficient Rx LP c6e46d6f-c64d-4242-a56f-8aff96e68993 2024-10-01 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE KENALOG-10 TRIAMCINOLONE ACETONIDE E.R. Squibb & Sons, L.L.C. ec04ecbb-2896-3feb-85fd-a64aba93b289 2024-08-26 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE KENALOG-40 TRIAMCINOLONE ACETONIDE E.R. Squibb & Sons, L.L.C. cf970688-cd77-b95c-4bd9-c541590e9722 2024-08-20 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals, Inc. 200bb913-a6ac-5a6b-e063-6294a90a161a 2024-08-19 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack 3d709ea2-060f-4b16-b1fd-191fb4484312 2024-08-15 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack 0bf47993-615c-4d89-8e02-145f59315362 2024-08-14 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide Nasal TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack ddcaf82b-3aaa-4dba-91be-8f71fce7a6e0 2024-08-14 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Teva Parenteral Medicines, Inc. 1680315d-dcdc-407a-b8e8-8710587197d2 2024-07-31 Warnings, Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide Nasal TRIAMCINOLONE ACETONIDE Padagis Israel Pharmaceuticals Ltd 8468115a-4f0c-4ae8-bcd6-38f8b81cf871 2024-07-25 Warnings Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone acetonide TRIAMCINOLONE ACETONIDE NuCare Pharmaceuticals,Inc. b43d4e4a-6206-4449-e053-2a95a90a721a 2024-07-17 Adverse reactions Name fallback generic name: TRIAMCINOLONE ACETONIDE Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE Bryant Ranch Prepack 69786597-99f9-4bdc-91bc-c50e5fd682c8 2024-06-26 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