Application 215556

Type: ANDA
Sponsor: VKT PHARMA

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 1.

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
A215556-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04
A215556-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04
A215556-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04
A215556-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215556-001	AB1
A215556-002	AB1
A215556-003	AB1
A215556-004	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 4 · 132 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
2026-02-19 14:30 UTC	2026-02	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215556-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215556-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215556-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215556-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215556-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215556-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215556-004	AB1	1	`d06236e962d9…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	6c680b37-d515-4fc2-83e6-411f1017e18c	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	PD-RX Pharmaceuticals, Inc.	fc7596dd-42d3-af7c-e053-6294a90af01e	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	5de70f00-00ac-4656-883e-d1e07d5f71d6	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	A-S Medication Solutions	b2d163aa-1056-47dd-85aa-297800e6c772	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	A-S Medication Solutions	00cbc656-768d-4995-bb6d-a0d4b32a248c	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	Burel Pharmaceuticals, LLC	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	VKT Pharma Private Limited	b4d9851c-5c06-4532-bd82-16d92b60c28f	2021-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556 ndc (product): 71821-008 ndc (product): 71821-007 ndc (product): 71821-006 ndc (product): 71821-009

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
71821-006	tadalafil	Tadalafil	VKT Pharma Private Limited	ANDA	Current
71821-007	tadalafil	Tadalafil	VKT Pharma Private Limited	ANDA	Current
71821-008	tadalafil	Tadalafil	VKT Pharma Private Limited	ANDA	Current
71821-009	tadalafil	Tadalafil	VKT Pharma Private Limited	ANDA	Current