Application 206426

Type
NDA
Sponsor
BIOCRYST

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAPIVABPERAMIVIRSOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206426-001RAPIVABPERAMIVIR200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206426-001103910752027-02-12U-26222019-09-25
N206426-001103910752027-02-12U-30692019-09-25
N206426-00187789972027-05-07U-16272015-01-13
N206426-00187789972027-05-07U-26222015-01-13
N206426-00187789972027-05-07U-30692015-01-13

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N206426-001RAPIVAB200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-12-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206426-001RAPIVAB200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-12-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206426-001RAPIVAB200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-12-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206426-001RAPIVAB200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2014-12-19a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 6 · 230 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N206426-001103910752027-02-12U-26222019-09-25c2088c7a36db…
2026-10-15 13:18:302026-09N206426-001103910752027-02-12U-30692019-09-25c2088c7a36db…
2026-10-15 13:18:302026-09N206426-00187789972027-05-07U-26222015-01-13c2088c7a36db…
2026-10-15 13:18:302026-09N206426-00187789972027-05-07U-16272015-01-13c2088c7a36db…
2026-10-15 13:18:302026-09N206426-00187789972027-05-07U-30692015-01-13c2088c7a36db…
2026-09-14 22:38:342026-08N206426-001103910752027-02-12U-26222019-09-2584e616aacf4f…
2026-09-14 22:38:342026-08N206426-001103910752027-02-12U-30692019-09-2584e616aacf4f…
2026-09-14 22:38:342026-08N206426-00187789972027-05-07U-26222015-01-1384e616aacf4f…
2026-09-14 22:38:342026-08N206426-00187789972027-05-07U-16272015-01-1384e616aacf4f…
2026-09-14 22:38:342026-08N206426-00187789972027-05-07U-30692015-01-1384e616aacf4f…
2026-08-18 06:07:402026-07N206426-001103910752027-02-12U-26222019-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N206426-001103910752027-02-12U-30692019-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N206426-00187789972027-05-07U-26222015-01-13caaa826d4ba7…
2026-08-18 06:07:402026-07N206426-00187789972027-05-07U-16272015-01-13caaa826d4ba7…
2026-08-18 06:07:402026-07N206426-00187789972027-05-07U-30692015-01-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206426-001103910752027-02-12U-26222019-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206426-001103910752027-02-12U-30692019-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206426-00187789972027-05-07U-26222015-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206426-00187789972027-05-07U-16272015-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206426-00187789972027-05-07U-30692015-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206426-001103910752027-02-12U-26222019-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206426-001103910752027-02-12U-30692019-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206426-00187789972027-05-07U-26222015-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206426-00187789972027-05-07U-16272015-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206426-00187789972027-05-07U-30692015-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N206426-001103910752027-02-12U-26222019-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206426-001103910752027-02-12U-30692019-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206426-00187789972027-05-07U-26222015-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206426-00187789972027-05-07U-16272015-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206426-00187789972027-05-07U-30692015-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206426-001103910752027-02-12U-26222019-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206426-001103910752027-02-12U-30692019-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206426-00187789972027-05-07U-26222015-01-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206426-00187789972027-05-07U-16272015-01-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206426-00187789972027-05-07U-30692015-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206426-001103910752027-02-12U-26222019-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206426-001103910752027-02-12U-30692019-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206426-00187789972027-05-07U-26222015-01-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206426-00187789972027-05-07U-16272015-01-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206426-00187789972027-05-07U-30692015-01-13b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N206426-001NCE2019-12-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206426-001NPP2020-09-2074a2ff9319b5…
2020-12-22 03:56 UTC2020-12N206426-001NPP2020-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206426-001NPP2020-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206426-001NCE2019-12-193f01610625f2…
2019-12-14 00:12 UTC2019-12N206426-001NPP2020-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09N206426-001NCE2019-12-19b00525d2431f…
2019-09-15 20:21 UTC2019-09N206426-001NPP2020-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N206426-001NCE2019-12-19ea99ee380514…
2019-07-19 19:46 UTC2019-07N206426-001NPP2020-09-20ea99ee380514…

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61364-181RapivabperamivirSeqirus USA Inc.NDACurrent
61364-181RapivabperamivirSeqirus USA Inc.NDACurrent
72769-181RapivabperamivirBioCryst Pharmaceuticals, Inc.NDACurrent
72769-181RapivabperamivirBioCryst Pharmaceuticals, Inc.NDACurrent
72769-181RapivabperamivirBioCryst Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78802SUPPL 2024-06-14
78799SUPPL 2024-06-14
66042SUPPL2021-02-01
66020SUPPL2021-01-29
54041SUPPL2018-05-08
54021SUPPL2018-05-04
49836SUPPL2017-09-22
49832SUPPL2017-09-22
45074SUPPL2016-08-17
45125SUPPL2016-08-12
44945ORIG2015-01-16
43520ORIG2015-01-16
40548ORIG2015-01-08
32808ORIG2014-12-23
53543SUPPL1900-01-01
51547SUPPL1900-01-01
51546SUPPL1900-01-01