Home Applications 211996 Application 211996
Type NDA
Sponsor FOLDRX PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYNDAQEL TAFAMIDIS MEGLUMINE CAPSULE;ORAL 20MG 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 N211996-001 VYNDAQEL TAFAMIDIS MEGLUMINE 20MG CAPSULE / ORAL RLD 2019-05-03
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 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 N211996-001 7214696 2026-12-19 U-2524 2019-05-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211996-001 ODE-237 2026-05-03
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 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD 2019-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD 2019-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD 2019-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 134 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 7214696 2023-12-19 U-2524 2019-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 8168663 2023-12-19 Drug substance, Drug product 2019-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 8653119 2024-01-28 U-2524 2019-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 7214695 2024-04-27 Drug substance, Drug product 2019-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211996-001 7214696 2023-12-19 U-2524 2019-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211996-001 8168663 2023-12-19 Drug substance, Drug product 2019-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211996-001 8653119 2024-01-28 U-2524 2019-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211996-001 7214695 2024-04-27 Drug substance, Drug product 2019-05-30 5d02ea3f76ae…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 2 · 78 observed states.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-1975 Vyndaqel tafamidis meglumine Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1975 Vyndaqel tafamidis meglumine Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1975 Vyndaqel tafamidis meglumine Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1975 Vyndaqel tafamidis meglumine Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1975 Vyndaqel tafamidis meglumine Pfizer Laboratories Div Pfizer Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 75878 SUPPL 2023-10-20 75876 SUPPL 2023-10-20 67667 SUPPL 2021-06-03 67648 SUPPL 2021-06-02 59056 ORIG 2019-06-13 58669 ORIG 2019-06-12 58562 ORIG 2019-05-03