Application 021368

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIALIS	TADALAFIL	TABLET;ORAL	5MG	Yes	No
002	CIALIS	TADALAFIL	TABLET;ORAL	10MG	Yes	No
003	CIALIS	TADALAFIL	TABLET;ORAL	20MG	Yes	Yes
004	CIALIS	TADALAFIL	TABLET;ORAL	2.5MG	Yes	No

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

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
N021368-001	CIALIS	TADALAFIL	5MG	TABLET / ORAL	AB1	RLD	2003-11-21
N021368-002	CIALIS	TADALAFIL	10MG	TABLET / ORAL	AB1	RLD	2003-11-21
N021368-003	CIALIS	TADALAFIL	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21
N021368-004	CIALIS	TADALAFIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021368-001	AB1
N021368-002	AB1
N021368-003	AB1

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 · 172 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	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-004	CIALIS	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-004	CIALIS	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-004	CIALIS	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-004	CIALIS	2.5MG	TABLET / ORAL	AB1	RLD	2008-01-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021368-004	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021368-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021368-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021368-003	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021368-004	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021368-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021368-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021368-003	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021368-004	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021368-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021368-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021368-003	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021368-004	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021368-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021368-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021368-003	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021368-004	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021368-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021368-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021368-003	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021368-004	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021368-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021368-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021368-003	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021368-004	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021368-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021368-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021368-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021368-003	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021368-004	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021368-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-003	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-004	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-003	AB1	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166	2020-04-26	U-1184		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166	2020-04-26	U-614		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166	2020-04-26	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	6943166	2020-04-26	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	6943166	2020-04-26	U-614		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	6943166	2020-04-26	U-614		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	7182958	2020-04-26	U-155	Drug product, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	7182958*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	6943166	2020-04-26	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	7182958	2020-04-26	U-155	Drug product, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	7182958*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166	2020-04-26	U-1184		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166	2020-04-26	U-614		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166	2020-04-26	U-155		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	6943166	2020-04-26	U-155		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	6943166	2020-04-26	U-614		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	6943166	2020-04-26	U-614		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	6943166	2020-04-26	U-155		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166	2020-04-26	U-1184		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166	2020-04-26	U-614		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166	2020-04-26	U-155		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-002	6943166	2020-04-26	U-155		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-002	6943166	2020-04-26	U-614		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-002	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-003	6943166	2020-04-26	U-614		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-003	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-004	6943166	2020-04-26	U-155		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-004	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021368-001	6943166	2020-04-26	U-1184		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021368-001	6943166	2020-04-26	U-614		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021368-001	6943166	2020-04-26	U-155		`3f01610625f2…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021368-001	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	PED	2021-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	PED	2021-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	PED	2021-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	PED	2021-08-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021368-001	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-001	PED	2021-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-002	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-002	PED	2021-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-003	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-003	PED	2021-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-004	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-004	PED	2021-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-001	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-001	PED	2021-08-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-002	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-002	PED	2021-08-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-003	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-003	PED	2021-08-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-004	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-004	PED	2021-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021368-001	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-001	PED	2021-08-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-002	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-002	PED	2021-08-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-003	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-003	PED	2021-08-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-004	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-004	PED	2021-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021368-001	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	PED	2021-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	PED	2021-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	PED	2021-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	PED	2021-08-15	`8869cabd3fbd…`

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
Cialis	TADALAFIL	Eli Lilly and Company	bcd8f8ab-81a2-4891-83db-24a0b0e25895	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021368 application number: NDA021368 ndc (product): 0002-4462 ndc (product): 0002-4464 ndc (product): 0002-4463

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 · 65 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-4462	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4462	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4462	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4462	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4463	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4463	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4463	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4463	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4464	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4464	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4464	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4464	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4465	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4465	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4465	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
0002-4465	Cialis	Tadalafil	Eli Lilly and Company	NDA	Current
21695-028	Cialis	Tadalafil	Rebel Distributors Corp.	NDA	Current
21695-029	Cialis	Tadalafil	Rebel Distributors Corp.	NDA	Current
43063-236	Cialis	Tadalafil	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-236	Cialis	Tadalafil	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-236	Cialis	Tadalafil	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-236	Cialis	Tadalafil	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-236	Cialis	Tadalafil	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43353-044	Cialis	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-044	Cialis	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-857	Cialis	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-857	Cialis	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50436-4462	Cialis	Tadalafil	Unit Dose Services	NDA	Current
50436-4463	Cialis	Tadalafil	Unit Dose Services	NDA	Current
50436-4464	Cialis	Tadalafil	Unit Dose Services	NDA	Current
50436-4465	Cialis	Tadalafil	Unit Dose Services	NDA	Current
50436-7001	Tadalafil	Tadalafil	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
50436-7010	Tadalafil	Tadalafil	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
55154-1830	Cialis	Tadalafil	Cardinal Health	NDA	Current
55154-1832	Cialis	Tadalafil	Cardinal Health	NDA	Current
63629-4601	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-4601	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-6367	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-6367	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-6769	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-6769	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-6769	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-7145	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-7145	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
63629-7145	Cialis	Tadalafil	Bryant Ranch Prepack	NDA	Current
66336-566	Cialis	Tadalafil	Dispensing Solutions, Inc.	NDA	Current
66993-700	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-700	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-700	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-700	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-701	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-701	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-701	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-701	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-702	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-702	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-702	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-702	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-702	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-703	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-703	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-703	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-703	Tadalafil	Tadalafil	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
71610-213	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-214	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52707	SUPPL	2018-02-23
52660	SUPPL	2018-02-16
52351	ORIG	2017-11-16
52350	ORIG	2017-11-16
52349	ORIG	2017-11-16
52348	ORIG	2017-11-16
48306	SUPPL	2017-05-09
48269	SUPPL	2017-05-08
36788	SUPPL	2016-04-29
5211	SUPPL	2016-04-26
15333	SUPPL	2015-09-23
5210	SUPPL	2015-09-17
15332	SUPPL	2014-05-02
27623	SUPPL	2014-04-30
21624	SUPPL	2014-01-17
36787	SUPPL	2013-10-17
5209	SUPPL	2013-10-11
27622	SUPPL	2011-10-12
5208	SUPPL	2011-10-12
36786	SUPPL	2011-10-07
15331	SUPPL	2011-10-07
15330	SUPPL	2010-02-16
5207	SUPPL	2010-02-16
5206	SUPPL	2008-08-13
5204	SUPPL	2008-01-09
15328	SUPPL	2008-01-08
5205	SUPPL	2007-10-22
15329	SUPPL	2007-10-18
27619	SUPPL	2007-01-25
15324	SUPPL	2007-01-24
27621	SUPPL	2006-10-26
5203	SUPPL	2006-10-26
15327	SUPPL	2006-10-25
15326	SUPPL	2006-10-25
27620	SUPPL	2006-03-23
15325	SUPPL	2006-03-10
44119	ORIG	2005-07-28
5202	SUPPL	2005-07-15
15323	SUPPL	2005-07-08
27618	SUPPL	2005-04-06
15322	SUPPL	2005-04-06
15321	SUPPL	2005-04-06
5201	SUPPL	2005-04-06
42124	ORIG	2004-03-08
43569	ORIG	2003-11-21
36785	ORIG	2003-11-21
5200	ORIG	2003-11-21
54084	SUPPL	1900-01-01
54083	SUPPL	1900-01-01
53531	ORIG	1900-01-01