Application 208960

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208960-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31
A208960-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31
A208960-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31
A208960-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A208960-001	AB
A208960-002	AB
A208960-003	AB
A208960-004	AB

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208960-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208960-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208960-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208960-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208960-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208960-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208960-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208960-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208960-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208960-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208960-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208960-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208960-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208960-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208960-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208960-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208960-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208960-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208960-004	AB	1	`d8e5a09893c0…`

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
VARDENAFIL	VARDENAFIL	Zydus Lifesciences Limited	8ea14f7e-44a0-4d9c-968a-87b97ca12f09	2026-01-05		Exact identifier application applno (ANDA): 208960 application number: ANDA208960 ndc (product): 70771-1050 ndc (product): 70771-1048 ndc (product): 70771-1047 ndc (product): 70771-1049
VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals USA Inc.	5876e062-e604-42a7-99c3-5da30b8dac06	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208960 application number: ANDA208960 ndc (product): 70710-1069 ndc (product): 70710-1071 ndc (product): 70710-1070 ndc (product): 70710-1068
VARDENAFIL	VARDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	c70a9c8e-46b0-489d-bbda-2d7fca4b629f	2020-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208960 application number: ANDA208960 ndc (product): 71610-477

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-174	VARDENAFIL	VARDENAFIL	Golden State Medical Supply, Inc.	ANDA	Current
51407-174	VARDENAFIL	VARDENAFIL	Golden State Medical Supply, Inc.	ANDA	Current
70710-1068	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1068	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1068	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1068	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1069	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1069	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1069	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1069	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1070	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1070	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1070	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1070	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1071	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1071	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1071	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1071	VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1047	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1047	VARDENAFIL	VARDENAFIL	Zydus Lifesciences Limited	ANDA	Current
70771-1047	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1047	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1048	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1048	VARDENAFIL	VARDENAFIL	Zydus Lifesciences Limited	ANDA	Current
70771-1048	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1048	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1049	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1049	VARDENAFIL	VARDENAFIL	Zydus Lifesciences Limited	ANDA	Current
70771-1049	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1049	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1050	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1050	VARDENAFIL	VARDENAFIL	Zydus Lifesciences Limited	ANDA	Current
70771-1050	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
70771-1050	VARDENAFIL	VARDENAFIL	Cadila Healthcare Limited	ANDA	Current
71610-477	VARDENAFIL	VARDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-477	VARDENAFIL	VARDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-643	VARDENAFIL	VARDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current