Details for New Drug Application (NDA): 218038
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NDA 218038 describes DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 218038
| Tradename: | DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE |
| Applicant: | Hq Spclt Pharma |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218038
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 218038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | diltiazem hydrochloride | SOLUTION;INTRAVENOUS | 218038 | NDA | WG Critical Care, LLC | 44567-662 | 44567-662-10 | 10 BAG in 1 CARTON (44567-662-10) / 100 mL in 1 BAG (44567-662-01) |
| DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | diltiazem hydrochloride | SOLUTION;INTRAVENOUS | 218038 | NDA | WG Critical Care, LLC | 44567-663 | 44567-663-10 | 10 BAG in 1 CARTON (44567-663-10) / 250 mL in 1 BAG (44567-663-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/100ML (1MG/ML) | ||||
| Approval Date: | Feb 21, 2025 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/250ML (1MG/ML) | ||||
| Approval Date: | Feb 21, 2025 | TE: | RLD: | Yes | |||||
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