Home Applications 019650 Application 019650
Type NDA
Sponsor FOREST LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUMADINE RIMANTADINE HYDROCHLORIDE SYRUP;ORAL 50MG/5ML No No
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 N019650-001 FLUMADINE RIMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL 1993-09-17
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 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019650-001 FLUMADINE 50MG/5ML SYRUP / ORAL 1993-09-17 cb3db0bc1861…
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.
Documents# Document, Submission type, Date table Document Submission type Date 17517 SUPPL 2008-01-09 1457 SUPPL 2007-03-23 11597 SUPPL 2007-03-15 17516 ORIG 2004-06-04 11596 ORIG 2004-06-04 33837 SUPPL 2001-04-11 1456 SUPPL 2001-04-11