Application 209057

Type: ANDA
Sponsor: CROSSMEDIKA SA

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	Approval date
A209057-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31
A209057-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31
A209057-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31
A209057-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	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
A209057-001	AB
A209057-002	AB
A209057-003	AB
A209057-004	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	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	A209057-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209057-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209057-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209057-004	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Lannett Company, Inc.	2782efed-6198-47b9-81ac-3e255e2ab7f6	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057 ndc (product): 0527-2800 ndc (product): 0527-2803 ndc (product): 0527-2801 ndc (product): 0527-2802
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	80c4793d-e19e-10f0-e053-2991aa0a4620	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057 ndc (product): 42291-848 ndc (product): 42291-847
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Chartwell RX, LLC	57a0c163-a5e8-4c6e-a4ea-114cb2668407	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	083a3282-254f-4042-b0eb-70f76a279f10	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	6d2859a7-6def-455f-856b-9db86b1fd355	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	666a622b-2464-4c55-8c90-0f1cc85bc1e9	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	8791997d-3b86-45af-988f-808e259da506	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	3b03952b-d404-09cd-e063-6294a90a8b2c	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	09366eb3-93e0-41d9-bf9a-24335ed3555f	2021-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057 ndc (product): 71610-508

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2800	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2800	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2800	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2800	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2801	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2801	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2801	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2801	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2802	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2802	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2802	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2802	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2803	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2803	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2803	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-2803	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Lannett Company, Inc.	ANDA	Current
42291-847	Vardenafil Hydrochloride	Vardenafil Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-847	Vardenafil Hydrochloride	Vardenafil Hydrochloride	AvKARE	ANDA	Current
42291-847	Vardenafil Hydrochloride	Vardenafil Hydrochloride	AvKARE	ANDA	Current
42291-848	Vardenafil Hydrochloride	Vardenafil Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-848	Vardenafil Hydrochloride	Vardenafil Hydrochloride	AvKARE	ANDA	Current
42291-848	Vardenafil Hydrochloride	Vardenafil Hydrochloride	AvKARE	ANDA	Current
71610-310	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-508	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current