Application 220100
- Type
- ANDA
- Sponsor
- BIONPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | SOLUTION;ORAL | 1MG/7.5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220100-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 |
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 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | 31067a03dcf5… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | 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 |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Kesin Pharma Corporation | 52e6ecc5-5f3d-9989-e063-6294a90af2dc | 2026-06-30 | Warnings | 220100 ANDA220100 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | DOLGENCORP INC | 4db35031-f765-39a6-e063-6394a90a40c9 | 2026-03-20 | Warnings | 220100 ANDA220100 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE ORAL | Bionpharma Inc. | 4bd0939e-c172-d962-e063-6394a90a44b5 | 2026-02-27 | Warnings | 220100 ANDA220100 |