Application 086576
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYZINE | TETRAHYDROZOLINE HYDROCHLORIDE | SOLUTION;NASAL | 0.1% | No | No |
| 002 | TYZINE | TETRAHYDROZOLINE HYDROCHLORIDE | SOLUTION;NASAL | 0.05% | No | Yes |
| 003 | TYZINE | TETRAHYDROZOLINE HYDROCHLORIDE | SPRAY;NASAL | 0.1% | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086576-001 | TYZINE | TETRAHYDROZOLINE HYDROCHLORIDE | 0.1% | SOLUTION / NASAL | Approved before 1982 | ||
| A086576-002 | TYZINE | TETRAHYDROZOLINE HYDROCHLORIDE | 0.05% | SOLUTION / NASAL | RS, Approved before 1982 | ||
| A086576-003 | TYZINE | TETRAHYDROZOLINE HYDROCHLORIDE | 0.1% | SPRAY / NASAL | RS, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A086576-001 | TYZINE | 0.1% | SOLUTION / NASAL | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086576-002 | TYZINE | 0.05% | SOLUTION / NASAL | RS, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086576-003 | TYZINE | 0.1% | SPRAY / NASAL | RS, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086576-001 | TYZINE | 0.1% | SOLUTION / NASAL | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086576-002 | TYZINE | 0.05% | SOLUTION / NASAL | RS, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086576-003 | TYZINE | 0.1% | SPRAY / NASAL | RS, Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086576-001 | TYZINE | 0.1% | SOLUTION / NASAL | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086576-002 | TYZINE | 0.05% | SOLUTION / NASAL | RS, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086576-003 | TYZINE | 0.1% | SPRAY / NASAL | RS, Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Medics Choice Eye Drops Original Redness Reliever | TETRAHYDROZOLINE HYDROCHLORIDE | KC Pharmaceuticals, Inc. | e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be | 2025-12-30 | Warnings | TETRAHYDROZOLINE HYDROCHLORIDE |
| Lil Drug Store Eye Drops Redness Reliever | TETRAHYDROZOLINE HYDROCHLORIDE | Lil Drug Store Products, Inc | d2a47e98-a04c-47ec-aded-d1c894f040e2 | 2024-12-30 | Warnings | TETRAHYDROZOLINE HYDROCHLORIDE |
| Visine Red Eye Comfort | TETRAHYDROZOLINE HYDROCHLORIDE | Kenvue Brands LLC | d7abd7cb-e094-481f-bea5-a5983e2c9ef4 | 2024-11-13 | Warnings | TETRAHYDROZOLINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.