Home Applications 021006 Application 021006
Type NDA
Sponsor ENDO PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FROVA FROVATRIPTAN SUCCINATE TABLET;ORAL EQ 2.5MG BASE Yes Yes
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 N021006-001 FROVA FROVATRIPTAN SUCCINATE EQ 2.5MG BASE TABLET / ORAL RLD 2001-11-08
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 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021006-001 FROVA EQ 2.5MG BASE TABLET / ORAL AB RLD, RS 2001-11-08 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0603-3718 Frovatriptan Succinate frovatriptan succinate Par Pharmaceutical NDA Current 50436-0026 FROVA frovatriptan succinate Unit Dose Services NDA Current 63481-025 FROVA frovatriptan succinate Endo Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 55326 SUPPL 2018-08-27 55254 SUPPL 2018-08-21 35866 SUPPL 2013-10-17 4021 SUPPL 2013-10-15 35865 SUPPL 2009-04-23 35864 SUPPL 2009-04-03 14148 SUPPL 2009-04-03 26463 SUPPL 2009-03-05 26462 SUPPL 2009-03-05 4020 SUPPL 2009-03-05 44086 ORIG 2003-12-09 35863 ORIG 2001-11-08 21350 ORIG 2001-11-08 4019 ORIG 2001-11-08