Application 091347
- Type
- ANDA
- Sponsor
- TEVA PHARMS
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091347-001 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2012-05-03 | |
| A091347-002 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-05-03 | |
| A091347-003 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-03 | |
| A091347-004 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091347-001 | AB |
| A091347-002 | AB |
| A091347-003 | AB |
| A091347-004 | 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 | 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 | A091347-001 | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2012-05-03 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091347-002 | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-05-03 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091347-003 | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-05-03 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091347-004 | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-05-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091347-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091347-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091347-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091347-004 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Bryant Ranch Prepack | 31be68b0-ac7e-42d0-9435-1f0a329b63d8 | 2024-04-03 | Warnings, Adverse reactions | 091347 ANDA091347 |
| Vardenafil Hydrochloride | VARDENAFIL HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | e593ab58-70a4-4095-8091-16a4b6d49e4d | 2023-12-08 | Warnings, Adverse reactions | 091347 ANDA091347 0093-7654 0093-7652 0093-7655 0093-7653 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7652 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7652 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7652 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7652 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7653 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7653 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7653 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7653 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7654 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7654 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7654 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7654 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7655 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7655 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7655 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7655 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |