Home Applications 078104 Application 078104
Type ANDA
Sponsor PERRIGO ISRAEL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE SPRAY, METERED;NASAL 0.055MG/SPRAY No No 002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE SPRAY, METERED;NASAL 0.055MG/SPRAY No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078104-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 A078104-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14
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 · 84 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 2026-08-18 06:07:40 2026-07 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 bb7c543d1eb4…
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 1 of 2 · 21 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 93 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0443 Good Sense Nasal Allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0113-0443 Good Sense Nasal Allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0113-0443 Good Sense Nasal Allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0113-0443 Good Sense Nasal Allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0113-7005 basic care nasal allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0113-7005 basic care nasal allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0113-7005 basic care nasal allergy Triamcinolone acetonide L. Perrigo Company ANDA Current 0363-0811 Allergy Nasal Triamcinolone acetonide Walgreen Company ANDA Current 0363-0811 Allergy Nasal Triamcinolone acetonide Walgreen Company ANDA Current 0363-0811 Allergy Nasal Triamcinolone acetonide Walgreen Company ANDA Current 0363-0811 Allergy Nasal Triamcinolone acetonide Walgreen Company ANDA Current 11673-717 Up and Up Nasal Allergy Triamcinolone acetonide Target Corporation ANDA Current 11673-717 Up and Up Nasal Allergy Triamcinolone acetonide Target Corporation ANDA Current 11673-717 Up and Up Nasal Allergy Triamcinolone acetonide Target Corporation ANDA Current 11822-0443 Nasal Allergy Triamcinolone acetonide Rite Aid Corporation ANDA Current 11822-0443 Nasal Allergy Triamcinolone acetonide Rite Aid Corporation ANDA Current 11822-0443 Nasal Allergy Triamcinolone acetonide Rite Aid Corporation ANDA Current 21130-443 Signature Care Nasal Allergy Triamcinolone acetonide Safeway ANDA Current 21130-443 Signature Care Nasal Allergy Triamcinolone acetonide Safeway ANDA Current 21130-443 Signature Care Nasal Allergy Triamcinolone acetonide Safeway ANDA Current 21130-443 Signature Care Nasal Allergy Triamcinolone acetonide Safeway ANDA Current 30142-443 24 Hour Nasal Allergy Triamcinolone acetonide Kroger Company ANDA Current 30142-443 24 Hour Nasal Allergy Triamcinolone acetonide Kroger Company ANDA Current 30142-443 24 Hour Nasal Allergy Triamcinolone acetonide Kroger Company ANDA Current 30142-813 nasal allergy Triamcinolone acetonide Kroger Company ANDA Current 30142-813 nasal allergy Triamcinolone acetonide Kroger Company ANDA Current 30142-813 nasal allergy Triamcinolone acetonide Kroger Company ANDA Current 30142-813 nasal allergy Triamcinolone acetonide Kroger Company ANDA Current 36800-621 Topcare Nasal Allergy Triamcinolone acetonide Topco Associates LLC ANDA Current 36800-621 Topcare Nasal Allergy Triamcinolone acetonide Topco Associates LLC ANDA Current 36800-621 Topcare Nasal Allergy Triamcinolone acetonide Topco Associates LLC ANDA Current 36800-621 Topcare Nasal Allergy Triamcinolone acetonide Topco Associates LLC ANDA Current 36800-621 Topcare Nasal Allergy Triamcinolone acetonide Topco Associates LLC ANDA Current 37012-443 nasal allergy Triamcinolone acetonide Shopko Stores Operating Co., LLC ANDA Current 37808-443 Nasal Allergy Triamcinolone acetonide H E B ANDA Current 37808-443 Nasal Allergy Triamcinolone acetonide H E B ANDA Current 37808-443 Nasal Allergy Triamcinolone acetonide H E B ANDA Current 37808-443 Nasal Allergy Triamcinolone acetonide H E B ANDA Current 41163-443 Equaline nasal allergy Triamcinolone acetonide Supervalu Inc ANDA Current 41163-443 Equaline nasal allergy Triamcinolone acetonide Supervalu Inc ANDA Current 41163-443 Equaline nasal allergy Triamcinolone acetonide Supervalu Inc ANDA Current 41163-443 Equaline nasal allergy Triamcinolone acetonide Supervalu Inc ANDA Current 41190-443 shoprite nasal allergy Triamcinolone acetonide Wakefern Food Corporation ANDA Current 41250-443 24 Hour Nasal Allergy Triamcinolone acetonide Meijer Distribution Inc ANDA Current 41250-443 24 Hour Nasal Allergy Triamcinolone acetonide Meijer Distribution Inc ANDA Current 41250-443 24 Hour Nasal Allergy Triamcinolone acetonide Meijer Distribution Inc ANDA Current 41250-443 24 Hour Nasal Allergy Triamcinolone acetonide Meijer Distribution Inc ANDA Current 41520-443 CareOne Allergy Relief Triamcinolone acetonide American Sales Company ANDA Current 41520-443 CareOne Allergy Relief Triamcinolone acetonide American Sales Company ANDA Current 41520-443 CareOne Allergy Relief Triamcinolone acetonide American Sales Company ANDA Current 45802-109 Triamcinolone Acetonide Nasal Triamcinolone acetonide Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-109 Triamcinolone Acetonide Nasal Triamcinolone acetonide Perrigo New York Inc ANDA Current 45802-109 Triamcinolone Acetonide Nasal Triamcinolone acetonide Perrigo New York Inc ANDA Current 46122-385 Good Neighbor Pharmacy 24 Hour Nasal Allergy Triamcinolone acetonide Amerisource Bergen ANDA Current 46122-385 Good Neighbor Pharmacy 24 Hour Nasal Allergy Triamcinolone acetonide Amerisource Bergen ANDA Current 46122-385 Good Neighbor Pharmacy 24 Hour Nasal Allergy Triamcinolone acetonide Amerisource Bergen ANDA Current 46122-385 Good Neighbor Pharmacy 24 Hour Nasal Allergy Triamcinolone acetonide Amerisource Bergen ANDA Current 49035-443 Equate Nasal Allergy Triamcinolone acetonide Wal-Mart Stores Inc ANDA Current 49035-443 Equate Nasal Allergy Triamcinolone acetonide Wal-Mart Stores Inc ANDA Current 49035-443 Equate Nasal Allergy Triamcinolone acetonide Wal-Mart Stores Inc ANDA Current 49035-443 Equate Nasal Allergy Triamcinolone acetonide Wal-Mart Stores Inc ANDA Current 49738-443 Smart Sense Nasal Allergy Triamcinolone acetonide Kmart Corporation ANDA Current 50804-085 NASAL Allergy 24 Hour Triamcinolone Acetonide Geiss, Destin & Dunn Inc. ANDA Current 55316-443 Healthy Accents Nasal Allergy Triamcinolone acetonide DZA Brands LLC ANDA Current 55910-280 DG Health Nasal Allergy Triamcinolone acetonide Dolgencorp, LLC ANDA Current 55910-280 DG Health Nasal Allergy Triamcinolone acetonide Dolgencorp, LLC ANDA Current 55910-280 DG Health Nasal Allergy Triamcinolone acetonide Dolgencorp, LLC ANDA Current 55910-280 DG Health Nasal Allergy Triamcinolone acetonide Dolgencorp, LLC ANDA Current 59779-746 Nasal Allergy Triamcinolone acetonide CVS Pharmacy ANDA Current 59779-746 Nasal Allergy Triamcinolone acetonide CVS Pharmacy ANDA Current 59779-746 Nasal Allergy Triamcinolone acetonide CVS Pharmacy ANDA Current 59779-746 Nasal Allergy Triamcinolone acetonide CVS Pharmacy ANDA Current 62011-0320 Health Mart 24 hour nasal allergy Triamcinolone acetonide Strategic Sourcing Services LLC ANDA Current 62011-0320 Health Mart 24 hour nasal allergy Triamcinolone acetonide Mckesson ANDA Current 62011-0320 Health Mart 24 hour nasal allergy Triamcinolone acetonide Strategic Sourcing Services LLC ANDA Current 62011-0320 Health Mart 24 hour nasal allergy Triamcinolone acetonide Strategic Sourcing Services LLC ANDA Current 62011-0320 Health Mart 24 hour nasal allergy Triamcinolone acetonide Strategic Sourcing Services LLC ANDA Current 62011-0320 Health Mart 24 hour nasal allergy Triamcinolone acetonide Strategic Sourcing Services LLC ANDA Current 63981-443 kirkland signature aller cort triamcinolone acetonide Costco Wholesale Company ANDA Current 63981-443 kirkland signature aller cort triamcinolone acetonide Costco Wholesale Company ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9117 ORIG 2009-08-06 18475 ORIG 2009-07-30