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 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	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.

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
2026-08-01 22:54:32	2026-06	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208960-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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