Application 202276

Type: NDA
Sponsor: METUCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STENDRA	AVANAFIL	TABLET;ORAL	50MG	Yes	No
002	STENDRA	AVANAFIL	TABLET;ORAL	100MG	Yes	No
003	STENDRA	AVANAFIL	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202276-001	STENDRA	AVANAFIL	50MG	TABLET / ORAL	AB	RLD	2012-04-27
N202276-002	STENDRA	AVANAFIL	100MG	TABLET / ORAL	AB	RLD	2012-04-27
N202276-003	STENDRA	AVANAFIL	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N202276-001	AB
N202276-002	AB
N202276-003	AB

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 · 129 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	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N202276-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202276-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 189 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202276-001	7501409	2023-05-05		Drug product		`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 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	N202276-001	M-282	2025-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	M-282	2025-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	M-282	2025-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	M-282	2025-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	M-282	2025-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	M-282	2025-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	M-282	2025-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	M-282	2025-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	M-282	2025-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	M-282	2025-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	M-282	2025-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	M-282	2025-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	M-282	2025-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	M-282	2025-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	M-282	2025-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	M-282	2025-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	M-282	2025-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	M-282	2025-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	M-282	2025-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	M-282	2025-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	M-282	2025-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	M-282	2025-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	M-282	2025-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	M-282	2025-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	M-282	2025-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	M-282	2025-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	M-282	2025-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	M-282	2025-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	M-282	2025-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	M-282	2025-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	M-282	2025-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-002	M-282	2025-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-003	M-282	2025-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-001	M-282	2025-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-002	M-282	2025-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-003	M-282	2025-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202276-001	M-282	2025-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-002	M-282	2025-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-003	M-282	2025-10-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202276-001	M-282	2025-10-18	`6a51e52b5d6a…`

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
Avanafil	AVANAFIL	Camber Pharmaceuticals, Inc.	1d04e17d-7399-430a-a8bb-fa1912b155e9	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: AVANAFIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62541-501	STENDRA	Avanafil	Vivus LLC	NDA	Current
62541-501	STENDRA	Avanafil	Vivus LLC	NDA	Current
62541-502	STENDRA	Avanafil	Vivus LLC	NDA	Current
62541-502	STENDRA	Avanafil	Vivus LLC	NDA	Current
62541-503	STENDRA	Avanafil	Vivus LLC	NDA	Current
62541-503	STENDRA	Avanafil	Vivus LLC	NDA	Current
72384-751	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-751	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-751	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-751	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-752	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-752	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-752	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-752	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-753	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-753	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-753	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
72384-753	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
76299-320	Stendra	avanafil	Mist Pharmaceuticals, LLC	NDA	Current
76299-320	Stendra	avanafil	Mist Pharmaceuticals, LLC	NDA	Current
76299-320	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
76299-321	Stendra	avanafil	Mist Pharmaceuticals, LLC	NDA	Current
76299-321	Stendra	avanafil	Mist Pharmaceuticals, LLC	NDA	Current
76299-321	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current
76299-322	Stendra	avanafil	Mist Pharmaceuticals, LLC	NDA	Current
76299-322	Stendra	avanafil	Mist Pharmaceuticals, LLC	NDA	Current
76299-322	Stendra	avanafil	Metuchen Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72444	SUPPL	2022-10-21
72407	SUPPL	2022-10-19
55126	SUPPL	2018-08-07
55121	SUPPL	2018-08-06
50028	SUPPL	2017-10-12
50007	SUPPL	2017-10-11
49561	SUPPL	2017-08-29
49441	SUPPL	2017-08-17
40159	SUPPL	2015-09-23
10014	SUPPL	2015-09-17
40158	SUPPL	2015-06-05
32224	SUPPL	2015-05-19
40157	SUPPL	2014-09-19
10013	SUPPL	2014-09-18
19311	SUPPL	2014-05-02
32223	SUPPL	2014-04-30
40156	SUPPL	2012-11-06
10012	SUPPL	2012-11-06
22882	ORIG	2012-06-04
19310	ORIG	2012-04-27
10011	ORIG	2012-04-27