Details for New Drug Application (NDA): 014879
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NDA 014879 describes DOPRAM, which is a drug marketed by Hikma and is included in one NDA. It is available from two suppliers. Additional details are available on the DOPRAM profile page.
The generic ingredient in DOPRAM is doxapram hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the doxapram hydrochloride profile page.
The generic ingredient in DOPRAM is doxapram hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the doxapram hydrochloride profile page.
Summary for 014879
| Tradename: | DOPRAM |
| Applicant: | Hikma |
| Ingredient: | doxapram hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 014879
| Physiological Effect | Increased Medullary Respiratory Drive |
Medical Subject Heading (MeSH) Categories for 014879
Suppliers and Packaging for NDA: 014879
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOPRAM | doxapram hydrochloride | INJECTABLE;INJECTION | 014879 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6018 | 0641-6018-01 | 20 mL in 1 VIAL (0641-6018-01) |
| DOPRAM | doxapram hydrochloride | INJECTABLE;INJECTION | 014879 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6018 | 0641-6018-06 | 6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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