Application 214031

Type: ANDA
Sponsor: ALEMBIC 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
A214031-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04
A214031-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04
A214031-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04
A214031-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214031-001	AB
A214031-002	AB
A214031-003	AB
A214031-004	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	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`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	A214031-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214031-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214031-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214031-004	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 HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	d8a5cc4b-9d9d-43af-9ee4-57381aa6368a	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214031 application number: ANDA214031
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	d2dce236-257e-44b6-93a9-9f0280257c6a	2023-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214031 application number: ANDA214031 ndc (product): 62332-238 ndc (product): 62332-239 ndc (product): 62332-236 ndc (product): 62332-237
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2023-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214031 application number: ANDA214031 ndc (product): 46708-237 ndc (product): 46708-236 ndc (product): 46708-239 ndc (product): 46708-238

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-236	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-237	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-238	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-239	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-236	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-236	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-236	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-237	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-237	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-237	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-238	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-238	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-238	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-239	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-239	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-239	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current