Application 087446
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 3% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087446-001 | CHLOROPROCAINE HYDROCHLORIDE | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE / INJECTION | 1982-04-16 |
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 | A087446-001 | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE / INJECTION | 1982-04-16 | 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 |
|---|---|---|---|---|---|---|
| Chloroprocaine Hydrochloride | CHLOROPROCAINE HYDROCHLORIDE | ProPharma Distribution | 4305ab6b-6038-9daa-e063-6294a90a018e | 2025-12-18 | Warnings, Adverse reactions | Chloroprocaine Hydrochloride CHLOROPROCAINE HYDROCHLORIDE |
| Nesacaine | CHLOROPROCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | a844e68a-1462-40e4-be5e-f56214906eb9 | 2022-09-01 | Warnings, Adverse reactions | CHLOROPROCAINE HYDROCHLORIDE |
| Chloroprocaine Hydrochloride | CHLOROPROCAINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e21e24d5-0535-4962-b9ed-7957fe4ed3db | 2022-02-25 | Warnings, Adverse reactions | Chloroprocaine Hydrochloride CHLOROPROCAINE HYDROCHLORIDE |