Application 210567

Type: ANDA
Sponsor: LUPIN LTD

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 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	Approval date
A210567-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A210567-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A210567-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A210567-004	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
A210567-001	AB1
A210567-002	AB1
A210567-003	AB1
A210567-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A210567-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210567-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210567-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210567-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210567-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210567-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210567-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210567-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210567-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210567-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210567-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210567-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210567-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210567-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210567-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210567-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210567-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210567-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210567-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210567-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210567-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210567-004	AB1	1	`5bbf6a4d5a75…`

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 5 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	XLCare Pharmaceuticals Inc.	add6afb8-d38c-47a2-8c35-d5940667bb0c	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	a84c1eab-5934-4e5d-8bb2-0734d6adba6a	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	A-S Medication Solutions	1580ab76-e229-4b8d-8c7b-82f39fecfebd	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	A-S Medication Solutions	b2d163aa-1056-47dd-85aa-297800e6c772	2024-10-16	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	A-S Medication Solutions	00cbc656-768d-4995-bb6d-a0d4b32a248c	2024-10-16	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Advanced Rx of Tennessee, LLC	248a4705-1403-e94a-e063-6294a90a3544	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	f2e8821e-04c9-4812-8c9e-39340775cc6e	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Alembic Pharmaceuticals Limited	741102c1-8809-44d4-9098-3dc8c0604764	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Solco Healthcare US, LLC	9489b635-385e-4a05-be02-df39fcafebe3	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	85ed0cbc-df84-44df-a9eb-f9587dbc21df	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	Bryant Ranch Prepack	ff3c7dd3-2dcc-498c-a121-1e2aa62c7a97	2024-08-16	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Zydus Lifesciences Limited	6c1c3a1f-80a4-417c-8830-5edbb9a0710f	2024-08-12		Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	185a3284-3a4f-44d3-9278-98581d33f95b	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
tadalafil	TADALAFIL	Proficient Rx LP	929e391e-b74b-4ccd-8690-16ffcece7a30	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	9f83ea2e-8ee8-ab6d-e053-2995a90a1e96	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	a0acad71-8ae3-2827-e053-2995a90a20b3	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Aurobindo Pharma Limited	a0ecc7cf-20dd-485a-b4dd-1bbc587280a7	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Aurobindo Pharma Limited	0345b81b-f946-4dd6-b49d-2a2bdd4c49c9	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a73b0e6f-09fc-42d6-a678-1409ce746bd1	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Tadalafil generic name: TADALAFIL
TADALAFIL	TADALAFIL	Asclemed USA, Inc.	101f44e4-669c-4e3d-843a-a27157750f9c	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: TADALAFIL generic name: TADALAFIL

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5627	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
68180-919	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-919	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-920	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-920	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-921	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-921	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-922	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-922	Tadalafil	Tadalafil	Lupin Pharmaceuticals, Inc.	ANDA	Current