Application 204632

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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
A204632-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22
A204632-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22
A204632-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22
A204632-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204632-001	AB
A204632-002	AB
A204632-003	AB
A204632-004	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 4 · 156 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	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	A204632-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204632-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204632-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-004	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	a38de6e1-21ca-4ebe-a3c7-6f849cf8b675	2023-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204632 application number: ANDA204632 ndc (product): 33342-152 ndc (product): 33342-153 ndc (product): 33342-154 ndc (product): 33342-151

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-151	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-151	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-151	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-152	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-152	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-152	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-153	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-153	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-153	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-154	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-154	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-154	Vardenafil Hydrochloride	Vardenafil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
73750-102	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-102	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-103	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-103	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-104	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-104	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-105	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current
73750-105	Vardenafil Hydrochloride	Vardenafil Hydrochloride	QYK BRANDS LLC	ANDA	Current