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 43 .
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 · 86 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 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 84e616aacf4f…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…
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.
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 2 of 2 · 93 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 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 66116-471 Triamcinolone Acetonide Triamcinolone Acetonide MedVantx, Inc. ANDA Current 69256-443 Harris Teeter Nasal Allergy Triamcinolone acetonide Harris Teeter, LLC ANDA Current 69256-443 Harris Teeter Nasal Allergy Triamcinolone acetonide Harris Teeter, LLC ANDA Current 69842-244 Childrens Nasal Allergy triamcinolone acetonide CVS Pharmacy ANDA Current 69842-244 Childrens Nasal Allergy triamcinolone acetonide CVS Pharmacy ANDA Current 70000-0204 Leader Nasal Allergy Triamcinolone acetonide Cardinal Health ANDA Current 70000-0204 Leader Nasal Allergy Triamcinolone acetonide Cardinal Health ANDA Current 70000-0204 Leader Nasal Allergy Triamcinolone acetonide Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0204 Leader Nasal Allergy Triamcinolone acetonide Cardinal Health 110, LLC. dba Leader ANDA Current 72288-443 Basic Care Nasal Allergy Triamcinolone acetonide Amazon.com Services LLC ANDA Current 72288-443 Basic Care Nasal Allergy Triamcinolone acetonide Amazon.com Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9117 ORIG 2009-08-06 18475 ORIG 2009-07-30