Application 210738

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A210738-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31
A210738-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31
A210738-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210738-002	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210738-003	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210738-001	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-10-31	`301d65b070ca…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	083a3282-254f-4042-b0eb-70f76a279f10	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	6d2859a7-6def-455f-856b-9db86b1fd355	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	666a622b-2464-4c55-8c90-0f1cc85bc1e9	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	8791997d-3b86-45af-988f-808e259da506	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Lannett Company, Inc.	2782efed-6198-47b9-81ac-3e255e2ab7f6	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	80c4793d-e19e-10f0-e053-2991aa0a4620	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Chartwell RX, LLC	57a0c163-a5e8-4c6e-a4ea-114cb2668407	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	3b03952b-d404-09cd-e063-6294a90a8b2c	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	d8a5cc4b-9d9d-43af-9ee4-57381aa6368a	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: VARDENAFIL HYDROCHLORIDE generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	31be68b0-ac7e-42d0-9435-1f0a329b63d8	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e593ab58-70a4-4095-8091-16a4b6d49e4d	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	a38de6e1-21ca-4ebe-a3c7-6f849cf8b675	2023-04-10	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	d2dce236-257e-44b6-93a9-9f0280257c6a	2023-03-22	Warnings, Adverse reactions	Name fallback brand name: VARDENAFIL HYDROCHLORIDE generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2023-01-24	Warnings, Adverse reactions	Name fallback brand name: VARDENAFIL HYDROCHLORIDE generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	09366eb3-93e0-41d9-bf9a-24335ed3555f	2021-01-27	Warnings, Adverse reactions	Name fallback brand name: Vardenafil Hydrochloride generic name: VARDENAFIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1151	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1151	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1151	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1151	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1152	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1152	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1152	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1152	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1153	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1153	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1153	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1153	Vardenafil hydrochloride	Vardenafil hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current