Application 209908

Type: ANDA
Sponsor: HETERO LABS LTD III

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
A209908-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209908-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209908-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209908-004	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
A209908-001	AB1
A209908-002	AB1
A209908-003	AB1
A209908-004	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	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-004	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	A209908-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209908-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209908-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209908-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209908-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209908-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209908-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209908-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209908-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209908-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209908-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209908-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209908-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209908-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209908-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209908-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209908-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209908-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209908-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209908-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209908-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209908-004	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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	NuCare Pharmaceutical,Inc.	48850075-ac57-abb7-e063-6394a90a7881	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209908 application number: ANDA209908
Tadalafil	TADALAFIL	NuCare Pharmaceuticals, Inc.	48892acb-43bb-a4d8-e063-6394a90a5d61	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209908 application number: ANDA209908
Tadalafil	TADALAFIL	XLCare Pharmaceuticals Inc.	add6afb8-d38c-47a2-8c35-d5940667bb0c	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209908 application number: ANDA209908
Tadalafil	TADALAFIL	A-S Medication Solutions	b9d71483-861b-465b-846b-d7bfd6cbac11	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209908 application number: ANDA209908
Tadalafil	TADALAFIL	A-S Medication Solutions	c1c8feb4-a85a-4f39-8c44-bc9cd77226f4	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209908 application number: ANDA209908 ndc (product): 50090-4660
Tadalafil	TADALAFIL	Camber Pharmaceuticals, Inc.	a3892605-4eb1-4d6e-a675-f7f7d4302f38	2019-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209908 application number: ANDA209908 ndc (product): 31722-644 ndc (product): 31722-643 ndc (product): 31722-645 ndc (product): 31722-646

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-643	Tadalafil	Tadalafil	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-644	Tadalafil	Tadalafil	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-645	Tadalafil	Tadalafil	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-646	Tadalafil	Tadalafil	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-4660	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
50090-4660	Tadalafil	Tadalafil	A-S Medication Solutions	ANDA	Current
50436-0644	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-0644	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-0644	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-0645	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-0645	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-6440	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
50436-6460	Tadalafil	Tadalafil	Unit Dose Services	ANDA	Current
61919-887	Tadalafil	Tadalafil	Direct_Rx	ANDA	Current
61919-887	Tadalafil	Tadalafil	Direct_Rx	ANDA	Current
61919-887	Tadalafil	Tadalafil	Direct_Rx	ANDA	Current
61919-889	Tadalafil	Tadalafil	Direct_Rx	ANDA	Current
68071-5092	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5092	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5110	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5110	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5116	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5116	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5138	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5138	Tadalafil	Tadalafil	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-1239	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1334	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71610-298	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current