Application 218038
- Type
- NDA
- Sponsor
- HQ SPCLT PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | Yes | Yes |
| 002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 250MG/250ML (1MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | |
| N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218038-001 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218038-002 | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-02-21 | 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 |
|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE | DILTIAZEM HYDROCHLORIDE | WG Critical Care, LLC | 8bae87a5-2137-467e-a1ad-79b2bc075e07 | 2025-04-15 | Warnings, Adverse reactions | 218038 NDA218038 |