Application 211335

Type: ANDA
Sponsor: SUNSHINE LAKE

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
A211335-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A211335-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A211335-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A211335-004	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
A211335-001	AB1
A211335-002	AB1
A211335-003	AB1
A211335-004	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 · 164 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	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211335-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211335-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211335-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211335-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A211335-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211335-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211335-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211335-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211335-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211335-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211335-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211335-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211335-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211335-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211335-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211335-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211335-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211335-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211335-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211335-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211335-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211335-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211335-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADALAFIL	TADALAFIL	HEC Pharm USA Inc.	a0f728b6-2cc6-cb65-e053-2a95a90ab142	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211335 application number: ANDA211335 ndc (product): 72303-0822 ndc (product): 72303-0823 ndc (product): 72303-0825 ndc (product): 72303-0824

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48792-7887	TADALAFIL	Tadalafil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7888	TADALAFIL	Tadalafil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7889	TADALAFIL	Tadalafil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7890	TADALAFIL	Tadalafil	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
72303-0822	TADALAFIL	Tadalafil	HEC Pharm USA Inc.	ANDA	Current
72303-0823	TADALAFIL	Tadalafil	HEC Pharm USA Inc.	ANDA	Current
72303-0824	TADALAFIL	Tadalafil	HEC Pharm USA Inc.	ANDA	Current
72303-0825	TADALAFIL	Tadalafil	HEC Pharm USA Inc.	ANDA	Current