Application 210608

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210608-001	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB2		2022-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210608-001	AB2

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210608-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2022-08-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210608-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210608-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210608-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210608-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210608-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210608-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210608-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210608-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210608-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210608-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210608-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210608-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210608-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210608-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210608-001	AB2	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210608-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210608-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210608-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210608-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210608-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210608-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210608-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210608-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210608-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210608-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210608-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210608-001	AB2	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210608-001	AB2	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADALAFIL	TADALAFIL	REMEDYREPACK INC.	cec49f6c-71f1-4de7-b515-1612ae16e5db	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210608 application number: ANDA210608
TADALAFIL	TADALAFIL	AvKARE	3c1c2136-099f-6232-e063-6294a90a6975	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210608 application number: ANDA210608
TADALAFIL	TADALAFIL	Solco Healthcare US, LLC	9489b635-385e-4a05-be02-df39fcafebe3	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210608 application number: ANDA210608 ndc (product): 43547-990

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-990	TADALAFIL	tadalafil	Solco Healthcare US, LLC	ANDA	Current