Application 209744

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TADALAFIL	TADALAFIL	TABLET;ORAL	2.5MG	No	No
002	TADALAFIL	TADALAFIL	TABLET;ORAL	5MG	No	No
003	TADALAFIL	TADALAFIL	TABLET;ORAL	10MG	No	No
004	TADALAFIL	TADALAFIL	TABLET;ORAL	20MG	No	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	Approval date
A209744-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209744-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209744-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209744-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209744-001	AB1
A209744-002	AB1
A209744-003	AB1
A209744-004	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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A209744-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209744-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209744-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209744-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209744-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209744-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-004	AB1	1	`d8e5a09893c0…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	Amneal Pharmaceuticals NY LLC	90f38460-62ad-492e-a3da-403d5a5a5d86	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (product): 69238-1346 ndc (product): 69238-1347 ndc (product): 69238-1348 ndc (product): 69238-1349
Tadalafil	TADALAFIL	AvKARE	b96ae7f1-7d4a-a211-e053-2995a90ab6e2	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (product): 42291-865 ndc (product): 42291-866 ndc (product): 42291-867 ndc (product): 42291-864
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	bce03930-14c5-401f-ad17-06b7709983bc	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (product): 71610-567
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	f2e8821e-04c9-4812-8c9e-39340775cc6e	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (product): 71610-581
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	d1dd9d05-e9d3-49ea-aeda-047536a27037	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (product): 71610-603
Tadalafil	TADALAFIL	Amneal Pharmaceuticals NY LLC	2cad2167-dbd1-4df8-b407-b270487d027b	2019-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (product): 60219-1349 ndc (product): 60219-1348 ndc (product): 60219-1347 ndc (product): 60219-1346

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-864	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-864	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-865	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-865	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-866	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-866	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-867	Tadalafil	Tadalafil	AvKARE	ANDA	Current
42291-867	Tadalafil	Tadalafil	AvKARE	ANDA	Current
60219-1346	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1347	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1348	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1349	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1346	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1346	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1346	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1346	Tadalafil	Tadalafil	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1347	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1347	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1347	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1347	Tadalafil	Tadalafil	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1348	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1348	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1348	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1348	Tadalafil	Tadalafil	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1349	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1349	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1349	Tadalafil	Tadalafil	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1349	Tadalafil	Tadalafil	Amneal Pharmaceuticals LLC	ANDA	Current
70518-3001	Tadalafil	Tadalafil	REMEDYREPACK INC.	ANDA	Current
70518-3001	Tadalafil	Tadalafil	REMEDYREPACK INC.	ANDA	Current
71335-1400	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1400	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71610-567	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-581	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-603	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current