Application 214522

Type: NDA
Sponsor: CMP DEV LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TADLIQ	TADALAFIL	SUSPENSION;ORAL	20MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214522-001	TADLIQ	TADALAFIL	20MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-06-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13
N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15
N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16
N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214522-001	TADLIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2022-06-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214522-001	12186322	2038-12-24	U-3397	Drug product	2025-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214522-001	11975006	2038-12-24	U-3397	Drug product	2024-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214522-001	11382917	2038-12-24	U-3397	Drug product	2022-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214522-001	11666576	2038-12-24	U-3397	Drug product	2023-06-15	`301d65b070ca…`

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
TADLIQ	TADALAFIL	CMP Pharma, Inc.	7a909b25-3772-403e-a5fe-e4a040293fb7	2022-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214522 application number: NDA214522 ndc (product): 46287-045

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
46287-045	TADLIQ	Tadalafil	CMP Pharma, Inc.	NDA	Current
46287-045	TADLIQ	Tadalafil	CMP Pharma, Inc.	NDA	Current
46287-045	TADLIQ	Tadalafil	CMP Pharma, Inc.	NDA	Current
46287-045	TADLIQ	Tadalafil	CMP Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73561	ORIG	2023-02-21
71416	ORIG	2022-06-21
71384	ORIG	2022-06-21