Details for New Drug Application (NDA): 215252
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NDA 215252 describes DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 215252
| Tradename: | DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% |
| Applicant: | Exela Pharma |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215252
| Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 215252
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | diltiazem hydrochloride | SOLUTION;INTRAVENOUS | 215252 | NDA | Exela Pharma Sciences,LLC | 51754-3000 | 51754-3000-3 | 10 BAG in 1 CARTON (51754-3000-3) / 125 mL in 1 BAG |
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | diltiazem hydrochloride | SOLUTION;INTRAVENOUS | 215252 | NDA | Exela Pharma Sciences,LLC | 51754-3500 | 51754-3500-3 | 10 BAG in 1 CARTON (51754-3500-3) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 28, 2021 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 28, 2021 | TE: | RLD: | Yes | |||||
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