Application 022334

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AFINITOR	EVEROLIMUS	TABLET;ORAL	5MG	Yes	Yes
002	AFINITOR	EVEROLIMUS	TABLET;ORAL	10MG	Yes	No
003	AFINITOR	EVEROLIMUS	TABLET;ORAL	2.5MG	Yes	No
004	AFINITOR	EVEROLIMUS	TABLET;ORAL	7.5MG	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	TE codes	RLD / RS	Approval date
N022334-001	AFINITOR	EVEROLIMUS	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30
N022334-002	AFINITOR	EVEROLIMUS	10MG	TABLET / ORAL	AB	RLD	2009-03-30
N022334-003	AFINITOR	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09
N022334-004	AFINITOR	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022334-001	AB
N022334-002	AB
N022334-003	AB
N022334-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022334-001	8410131	2025-11-01	U-1368		2013-04-02
N022334-001	8410131*PED	2026-05-01		Pediatric extension
N022334-001	9006224	2028-07-01	U-1681		2015-04-20
N022334-002	8410131	2025-11-01	U-1368		2013-04-02
N022334-002	8410131*PED	2026-05-01		Pediatric extension
N022334-002	9006224	2028-07-01	U-1681		2015-04-20
N022334-003	8410131	2025-11-01	U-1368		2013-04-02
N022334-003	8410131*PED	2026-05-01		Pediatric extension
N022334-003	9006224	2028-07-01	U-1681		2015-04-20
N022334-004	8410131	2025-11-01	U-1368		2013-04-02
N022334-004	8410131*PED	2026-05-01		Pediatric extension
N022334-004	9006224	2028-07-01	U-1681		2015-04-20

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 5 · 168 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
2026-08-18 06:07:40	2026-07	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022334-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022334-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022334-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022334-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022334-004	AB	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 888 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	8410131*PED	2026-05-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	9006224	2028-07-01	U-1681		2015-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	8410131	2025-11-01	U-1368		2013-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	8410131*PED	2026-05-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	9006224	2028-07-01	U-1681		2015-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	8410131	2025-11-01	U-1368		2013-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	8410131*PED	2026-05-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	9006224	2028-07-01	U-1681		2015-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	8410131*PED	2026-05-01		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	9006224	2028-07-01	U-1681		2015-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	8410131	2025-11-01	U-1368		2013-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	8410131*PED	2026-05-01		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	9006224	2028-07-01	U-1681		2015-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	8410131	2025-11-01	U-1368		2013-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	8410131*PED	2026-05-01		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	9006224	2028-07-01	U-1681		2015-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-001	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-002	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-003	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-004	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022334-001	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022334-002	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022334-003	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022334-004	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022334-001	ODE-108	2023-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022334-002	ODE-108	2023-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022334-003	ODE-108	2023-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022334-004	ODE-108	2023-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022334-001	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-001	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-001	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-001	ODE-108	2023-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	ODE-108	2023-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	ODE-108	2023-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	ODE-108	2023-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022334-001	ODE-108	2023-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022334-002	ODE-108	2023-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022334-003	ODE-108	2023-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022334-004	ODE-108	2023-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022334-001	ODE-108	2023-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022334-002	ODE-108	2023-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022334-003	ODE-108	2023-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022334-004	ODE-108	2023-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-001	ODE-108	2023-02-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-002	ODE-108	2023-02-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-003	ODE-108	2023-02-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-004	ODE-108	2023-02-26	`87673890dc5c…`

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
Afinitor	EVEROLIMUS	Novartis Pharmaceuticals Corporation	2150f73a-179b-4afc-b8ce-67c85cc72f04	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022334 application number: NDA022334 ndc (product): 0078-0567 ndc (product): 0078-0594 ndc (product): 0078-0620 ndc (product): 0078-0566

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70061	SUPPL	2022-02-03
70047	SUPPL	2022-02-02
69930	SUPPL	2022-01-20
67110	SUPPL	2021-04-19
67103	SUPPL	2021-04-19
61896	SUPPL	2020-02-14
61891	SUPPL	2020-02-14
61629	SUPPL	2020-01-23
61624	SUPPL	2020-01-23
53655	SUPPL	2018-04-12
53647	SUPPL	2018-04-11
49876	SUPPL	2017-09-28
49868	SUPPL	2017-09-28
17269	SUPPL	2016-06-17
29618	SUPPL	2016-06-16
7264	SUPPL	2016-02-29
38597	SUPPL	2016-02-26
7263	SUPPL	2016-02-23
38596	SUPPL	2016-02-11
7262	SUPPL	2016-02-05
17268	SUPPL	2016-02-02
7261	SUPPL	2016-02-01
17267	SUPPL	2015-09-23
7260	SUPPL	2015-09-22
38595	SUPPL	2015-05-27
7259	SUPPL	2015-05-26
17266	SUPPL	2015-01-29
7258	SUPPL	2015-01-26
29617	SUPPL	2014-12-19
17265	SUPPL	2014-12-19
7257	SUPPL	2014-07-03
17264	SUPPL	2014-07-02
38594	SUPPL	2014-02-21
29616	SUPPL	2014-02-21
29615	SUPPL	2014-02-21
29614	SUPPL	2014-02-21
17263	SUPPL	2014-02-21
17261	SUPPL	2014-02-21
17262	SUPPL	2013-11-08
7256	SUPPL	2013-11-07
42494	SUPPL	2013-10-21
17260	SUPPL	2012-08-31
7255	SUPPL	2012-08-31
7253	SUPPL	2012-07-23
38592	SUPPL	2012-07-20
7254	SUPPL	2012-05-02
38593	SUPPL	2012-04-26
38591	SUPPL	2012-04-02
29613	SUPPL	2012-04-02
29612	SUPPL	2012-04-02
17259	SUPPL	2012-04-02
29611	SUPPL	2011-05-10
7252	SUPPL	2011-05-10
38590	SUPPL	2011-05-06
17258	SUPPL	2011-05-06
7251	SUPPL	2010-11-04
17257	SUPPL	2010-11-01
7250	SUPPL	2010-07-14
17256	SUPPL	2010-07-12
29610	SUPPL	2010-05-18
17255	SUPPL	2010-05-17
51730	ORIG	2010-04-01
24285	ORIG	2009-05-15
21997	ORIG	2009-05-15
29609	ORIG	2009-04-03
17254	ORIG	2009-04-03
54060	ORIG	1900-01-01
53272	ORIG	1900-01-01