Application 219661
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | TABLET;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219661-001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | 1GM | TABLET / ORAL | AB | 2025-03-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219661-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219661-001 | METHENAMINE HIPPURATE | 1GM | TABLET / ORAL | AB | 2025-03-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219661-001 | METHENAMINE HIPPURATE | 1GM | TABLET / ORAL | AB | 2025-03-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219661-001 | METHENAMINE HIPPURATE | 1GM | TABLET / ORAL | AB | 2025-03-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A219661-001 | METHENAMINE HIPPURATE | 1GM | TABLET / ORAL | AB | 2025-03-10 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219661-001 | METHENAMINE HIPPURATE | 1GM | TABLET / ORAL | AB | 2025-03-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219661-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219661-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219661-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A219661-001 | AB | 1 | fd3edfee7708… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219661-001 | AB | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methenamine hippurate | METHENAMINE HIPPURATE | Zydus Lifesciences Limited | 7e0d13d1-e564-4f3e-9054-65161eddfc57 | 2025-03-12 | 219661 ANDA219661 | |
| Methenamine hippurate | METHENAMINE HIPPURATE | Viona Pharmaceuticals Inc | 759b3725-0934-4974-a3ac-59a20aee81c6 | 2024-06-13 | Warnings, Adverse reactions | 219661 ANDA219661 |