Home Applications 019649 Application 019649
Type NDA
Sponsor SUN PHARM INDS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUMADINE RIMANTADINE HYDROCHLORIDE TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019649-001 FLUMADINE RIMANTADINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-17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 · 43 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 N019649-001 FLUMADINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019649-001 FLUMADINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019649-001 FLUMADINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019649-001 FLUMADINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019649-001 FLUMADINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019649-001 FLUMADINE 100MG TABLET / ORAL RLD 1993-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019649-001 FLUMADINE 100MG TABLET / ORAL AB RLD, RS 1993-09-17 f41ea6bd6efb…
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 · 1 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 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49708-521 Flumadine flumadine Caraco Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 17515 SUPPL 2010-04-08 11595 SUPPL 2010-04-07 33836 SUPPL 2009-01-21 1455 SUPPL 2008-11-25 17514 SUPPL 2008-01-09 17513 SUPPL 2007-03-23 33835 SUPPL 2007-03-15 11594 SUPPL 2004-06-04 1454 SUPPL 2001-04-11