Home Applications 021450 Application 021450
Type NDA
Sponsor ASTRAZENECA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 003 ZOMIG ZOLMITRIPTAN SPRAY;NASAL 2.5MG/SPRAY Yes No 004 ZOMIG ZOLMITRIPTAN SPRAY;NASAL 5MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021450-003 ZOMIG ZOLMITRIPTAN 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 N021450-004 ZOMIG ZOLMITRIPTAN 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL RLD 2013-09-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL RLD, RS 2003-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 60 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 6750237 2020-11-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 7220767 2020-11-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 6750237*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 7220767*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-004 6750237*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-004 7220767*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-003 6750237*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-003 7220767*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-004 6750237*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-004 7220767*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021450-003 6750237*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021450-003 7220767*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021450-004 6750237*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021450-004 7220767*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 6750237 2020-11-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 7220767 2020-11-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 6750237*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 7220767*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-003 6750237*PED 2021-05-28 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-003 7220767*PED 2021-05-28 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 6750237 2020-11-28 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 7220767 2020-11-28 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 6750237*PED 2021-05-28 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 7220767*PED 2021-05-28 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 3f01610625f2…
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-955 ZOMIG Zolmitriptan Rebel Distributors Corp NDA Current 64896-681 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-681 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-681 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-681 ZOMIG Zolmitriptan Impax Specialty Pharma NDA Current 64896-681 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-682 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-682 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-682 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 64896-682 ZOMIG Zolmitriptan Impax Specialty Pharma NDA Current 64896-682 ZOMIG Zolmitriptan Amneal Pharmaceuticals NDA Current 69238-2006 Zolmitriptan Zolmitriptan Amneal Pharmaceuticals NDA AUTHORIZED GENERIC Current 69238-2006 Zolmitriptan Zolmitriptan Amneal Pharmaceuticals NDA AUTHORIZED GENERIC Current 69238-2007 Zolmitriptan Zolmitriptan Amneal Pharmaceuticals NDA AUTHORIZED GENERIC Current 69238-2007 Zolmitriptan Zolmitriptan Amneal Pharmaceuticals NDA AUTHORIZED GENERIC Current