Home NDC 69621-812 Ticalast
Product NDC 69621-812
11-digit product format 696210812
Labeler code 69621
Product ID 69621-812_46027a67-5cfa-4caf-9f46-75b074662d61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelastine hydrochloride and fluticasone propionate
Dosage form KIT
Labeler Shoreline Pharmaceuticals, Inc.
Application NDA202236
Marketing category NDA
Marketing start 2016-09-28
Marketing end 0000-00-00
Active strength 0
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69621-812-00 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69621-812-00 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69621-812-00 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69621-812-00 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69621-812-00 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69621-812-00 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69621-812-00 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69621-812-00 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69621-812-00 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69621-812-00 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69621-812-00 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69621-812-00 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N202236-001 DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202236-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202236-001 8168620 2026-02-24 Drug product 2012-05-11 N202236-001 8168620*PED 2026-08-24 Pediatric extension
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 309 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202236-001 8168620*PED 2026-08-24 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202236-001 8168620*PED 2026-08-24 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202236-001 8168620*PED 2026-08-24 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202236-001 8168620*PED 2026-08-24 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202236-001 8168620*PED 2026-08-24 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 8163723*PED 2024-02-29 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 8168620*PED 2026-08-24 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 8163723*PED 2024-02-29 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 8168620*PED 2026-08-24 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 8163723*PED 2024-02-29 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 8168620*PED 2026-08-24 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 8163723*PED 2024-02-29 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 8168620*PED 2026-08-24 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202236-001 8163723*PED 2024-02-29 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202236-001 8168620*PED 2026-08-24 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 8163723*PED 2024-02-29 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 8168620*PED 2026-08-24 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 8163723*PED 2024-02-29 Pediatric extension 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 8168620*PED 2026-08-24 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 8163723*PED 2024-02-29 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 8168620*PED 2026-08-24 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202236-001 8163723*PED 2024-02-29 Pediatric extension 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202236-001 8168620*PED 2026-08-24 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202236-001 9259428 2023-06-13 U-644 2016-03-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202236-001 9901585 2023-06-13 Drug product 2018-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202236-001 8163723 2023-08-29 U-644 2012-05-11 5c6f7cd8ea54…
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 1 · 2 matching rows.