Application 212123

Type: NDA
Sponsor: AVID RADIOPHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAUVID	FLORTAUCIPIR F18	INJECTABLE;INJECTION	370MBQ(10MCI)	Yes	No
002	TAUVID	FLORTAUCIPIR F-18	SOLUTION;INTRAVENOUS	50ML (8.1-51mCi/ML)	Yes	Yes
003	TAUVID	FLORTAUCIPIR F-18	SOLUTION;INTRAVENOUS	50ML (8.1-100mCi/ML)	Yes	No
004	TAUVID	FLORTAUCIPIR F-18	SOLUTION;INTRAVENOUS	100ML (8.1-100mCi/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212123-001	TAUVID	FLORTAUCIPIR F-18	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28
N212123-002	TAUVID	FLORTAUCIPIR F-18	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28
N212123-003	TAUVID	FLORTAUCIPIR F-18	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01
N212123-004	TAUVID	FLORTAUCIPIR F-18	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N212123-001	8932557	2032-05-26	Drug substance	2020-06-11
N212123-002	8932557	2032-05-26	Drug substance	2020-06-11
N212123-003	8932557	2032-05-26	Drug substance	2022-09-08
N212123-004	8932557	2032-05-26	Drug substance	2022-09-08

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 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-001	TAUVID	30ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-002	TAUVID	50ML (8.1-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2020-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-003	TAUVID	50ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-004	TAUVID	100ML (8.1-100mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-01	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-001	8932557	2032-05-26	Drug substance	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-002	8932557	2032-05-26	Drug substance	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-003	8932557	2032-05-26	Drug substance	2022-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-004	8932557	2032-05-26	Drug substance	2022-09-08	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-001	NCE	2025-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212123-002	NCE	2025-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212123-001	NCE	2025-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212123-002	NCE	2025-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-001	NCE	2025-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212123-002	NCE	2025-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-001	NCE	2025-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212123-002	NCE	2025-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-001	NCE	2025-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212123-002	NCE	2025-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-001	NCE	2025-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212123-002	NCE	2025-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-001	NCE	2025-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212123-002	NCE	2025-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-001	NCE	2025-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212123-002	NCE	2025-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212123-001	NCE	2025-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212123-002	NCE	2025-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212123-001	NCE	2025-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212123-002	NCE	2025-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212123-001	NCE	2025-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212123-002	NCE	2025-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212123-001	NCE	2025-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212123-002	NCE	2025-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212123-001	NCE	2025-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212123-002	NCE	2025-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212123-001	NCE	2025-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212123-002	NCE	2025-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212123-001	NCE	2025-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212123-002	NCE	2025-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212123-001	NCE	2025-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212123-002	NCE	2025-05-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212123-001	NCE	2025-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212123-002	NCE	2025-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212123-001	NCE	2025-05-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212123-002	NCE	2025-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212123-001	NCE	2025-05-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212123-002	NCE	2025-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212123-001	NCE	2025-05-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212123-002	NCE	2025-05-28	`5aa47cf7b7d7…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TAUVID	FLORTAUCIPIR F-18	Eli Lilly and Company	b483abad-5230-462a-adfb-1a65160f01d0	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212123 application number: NDA212123 ndc (product): 0002-1220

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-1210	TAUVID	Flortaucipir F-18	Eli Lilly and Company	NDA	Current
0002-1210	TAUVID	Flortaucipir F-18	Eli Lilly and Company	NDA	Current
0002-1210	TAUVID	Flortaucipir F-18	Eli Lilly and Company	NDA	Current
0002-1220	TAUVID	Flortaucipir F-18	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77408	SUPPL	2024-02-07
77402	SUPPL	2024-02-06
74962	SUPPL	2023-07-31
63943	ORIG	2020-07-16
63363	ORIG	2020-06-01
63334	ORIG	2020-05-29