Application 208934

Type: ANDA
Sponsor: SUN PHARM

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
A208934-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A208934-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A208934-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A208934-004	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
A208934-001	AB1
A208934-002	AB1
A208934-003	AB1
A208934-004	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	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208934-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208934-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208934-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208934-004	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	A208934-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208934-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208934-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208934-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208934-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208934-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208934-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208934-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208934-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208934-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208934-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208934-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208934-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208934-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208934-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208934-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208934-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208934-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208934-004	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	A-S Medication Solutions	a84c1eab-5934-4e5d-8bb2-0734d6adba6a	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	A-S Medication Solutions	1580ab76-e229-4b8d-8c7b-82f39fecfebd	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a73b0e6f-09fc-42d6-a678-1409ce746bd1	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934 ndc (product): 71335-1255
Tadalafil	TADALAFIL	Bryant Ranch Prepack	6fd94914-0c9d-4268-8ed8-3c2690707a5d	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934 ndc (product): 71335-1884
Tadalafil	TADALAFIL	Bryant Ranch Prepack	a3190ceb-fb3f-45f7-a12d-4c333edaadc6	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934 ndc (product): 63629-8157
Tadalafil	TADALAFIL	NorthStar RxLLC	594acc15-a5bc-43b5-9659-a864b2c46eea	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934 ndc (product): 16714-074 ndc (product): 16714-076 ndc (product): 16714-075 ndc (product): 16714-077
Tadalafil	TADALAFIL	Sun Pharmaceutical Industries, Inc.	168a135b-1454-4def-9b03-c9a470bfcb5f	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934 ndc (product): 47335-010 ndc (product): 47335-012 ndc (product): 47335-011 ndc (product): 47335-009
Tadalafil	TADALAFIL	Asclemed USA, Inc.	30ae58ed-5b56-4513-8eb3-eb4f89b78f9d	2023-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208934 application number: ANDA208934

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-074	Tadalafil	Tadalafil	NorthStar RxLLC	ANDA	Current
16714-075	Tadalafil	Tadalafil	NorthStar RxLLC	ANDA	Current
16714-076	Tadalafil	Tadalafil	NorthStar RxLLC	ANDA	Current
16714-077	Tadalafil	Tadalafil	NorthStar RxLLC	ANDA	Current
47335-009	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-009	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-009	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-010	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-010	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-010	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-011	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-011	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-011	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-012	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-012	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-012	Tadalafil	Tadalafil	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-8157	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
63629-8157	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
63629-8157	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1255	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1255	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1255	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71335-1884	Tadalafil	Tadalafil	Bryant Ranch Prepack	ANDA	Current
71610-324	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-325	Tadalafil	Tadalafil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current