Application 219608
- Type
- ANDA
- Sponsor
- QILU PHARM HAINAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219608-001 | NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE / INJECTION | AP | 2025-10-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219608-001 | AP |
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 | A219608-001 | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE / INJECTION | AP | 2025-10-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219608-001 | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE / INJECTION | AP | 2025-10-28 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219608-001 | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE / INJECTION | AP | 2025-10-28 | 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 | A219608-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219608-001 | AP | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219608-001 | AP | 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 |
|---|---|---|---|---|---|---|
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Sagent Pharmaceuticals | c576c9d5-853b-4e93-be6c-3579dfa5564c | 2025-12-29 | Warnings, Adverse reactions | 219608 ANDA219608 |
| Nicardipine Hydrochloride | NICARDIPINE HYDROCHLORIDE | Qilu Pharmaceutical Co., Ltd. | 7433b5cd-9c3a-428a-bcaf-00f02cd52633 | 2025-04-23 | Warnings, Adverse reactions | 219608 ANDA219608 |