Application 202008

Type: NDA
Sponsor: AVID RADIOPHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMYVID	FLORBETAPIR F-18	SOLUTION;INTRAVENOUS	10ML (13.5-51mCi/ML)	No	No
002	AMYVID	FLORBETAPIR F-18	SOLUTION;INTRAVENOUS	10-30ML (13.5-51mCi/ML)	Yes	Yes
003	AMYVID	FLORBETAPIR F-18	SOLUTION;INTRAVENOUS	10-50ML (13.5-51mCi/ML)	Yes	Yes
004	AMYVID	FLORBETAPIR F-18	SOLUTION;INTRAVENOUS	10-100ML (13.5-51mCi/ML)	Yes	Yes

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

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
N202008-001	AMYVID	FLORBETAPIR F-18	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06
N202008-002	AMYVID	FLORBETAPIR F-18	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06
N202008-003	AMYVID	FLORBETAPIR F-18	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06
N202008-004	AMYVID	FLORBETAPIR F-18	10-100ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-13

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202008-001	7687052	2027-04-30	U-4217	Drug substance, Drug product	2012-05-04
N202008-001	8506929	2027-04-30	U-4217	Drug substance, Drug product	2013-09-06
N202008-002	7687052	2027-04-30	U-4217	Drug substance, Drug product
N202008-002	8506929	2027-04-30	U-4217	Drug substance, Drug product
N202008-003	7687052	2027-04-30	U-4217	Drug substance, Drug product
N202008-003	8506929	2027-04-30	U-4217	Drug substance, Drug product
N202008-004	7687052	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23
N202008-004	8506929	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23

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 3 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202008-004	AMYVID	10-100ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202008-004	AMYVID	10-100ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202008-002	AMYVID	10-30ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD	2012-04-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202008-003	AMYVID	10-50ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-04-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202008-004	AMYVID	10-100ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202008-001	AMYVID	10ML (13.5-51mCi/ML)	SOLUTION / INTRAVENOUS		2012-04-06	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 278 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N202008-001	7687052	2027-04-30	U-4217	Drug substance, Drug product	2012-05-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-001	8506929	2027-04-30	U-4217	Drug substance, Drug product	2013-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-002	7687052	2027-04-30	U-4217	Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-002	8506929	2027-04-30	U-4217	Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-003	7687052	2027-04-30	U-4217	Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-003	8506929	2027-04-30	U-4217	Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-004	7687052	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202008-004	8506929	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202008-001	7687052	2027-04-30	U-4217	Drug substance, Drug product	2012-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-001	8506929	2027-04-30	U-4217	Drug substance, Drug product	2013-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-002	7687052	2027-04-30	U-4217	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-002	8506929	2027-04-30	U-4217	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-003	7687052	2027-04-30	U-4217	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-003	8506929	2027-04-30	U-4217	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-004	7687052	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202008-004	8506929	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202008-001	7687052	2027-04-30	U-4217	Drug substance, Drug product	2012-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-001	8506929	2027-04-30	U-4217	Drug substance, Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-002	7687052	2027-04-30	U-4217	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-002	8506929	2027-04-30	U-4217	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-003	7687052	2027-04-30	U-4217	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-003	8506929	2027-04-30	U-4217	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-004	7687052	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202008-004	8506929	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202008-001	7687052	2027-04-30	U-4217	Drug substance, Drug product	2012-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-001	8506929	2027-04-30	U-4217	Drug substance, Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-002	7687052	2027-04-30	U-4217	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-002	8506929	2027-04-30	U-4217	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-003	7687052	2027-04-30	U-4217	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-003	8506929	2027-04-30	U-4217	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-004	7687052	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202008-004	8506929	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-001	7687052	2027-04-30	U-4217	Drug substance, Drug product	2012-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-001	8506929	2027-04-30	U-4217	Drug substance, Drug product	2013-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-002	7687052	2027-04-30	U-4217	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-002	8506929	2027-04-30	U-4217	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-003	7687052	2027-04-30	U-4217	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-003	8506929	2027-04-30	U-4217	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-004	7687052	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202008-004	8506929	2027-04-30	U-4217	Drug substance, Drug product	2025-07-23	`31067a03dcf5…`

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
Amyvid	FLORBETAPIR F 18	Eli Lilly and Company	bb5a5043-0f51-11df-8a39-0800200c9a66	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202008 application number: NDA202008 ndc (product): 0002-1200

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-1200	Amyvid	Florbetapir F 18	Eli Lilly and Company	NDA	Current
0002-1200	Amyvid	Florbetapir F 18	Eli Lilly and Company	NDA	Current
0002-1200	Amyvid	Florbetapir F 18	Eli Lilly and Company	NDA	Current
0002-1200	Amyvid	Florbetapir F 18	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83047	SUPPL	2025-08-05
83046	SUPPL	2025-08-05
83045	SUPPL	2025-08-05
82652	SUPPL	2025-06-24
82649	SUPPL	2025-06-24
61442	SUPPL	2019-12-26
61388	SUPPL	2019-12-23
19044	SUPPL	2013-12-17
9941	SUPPL	2013-12-16
43377	ORIG	2012-05-03
19043	ORIG	2012-04-09
32150	ORIG	2012-04-06