Details for New Drug Application (NDA): 018227
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NDA 018227 describes AMIDATE, which is a drug marketed by Hospira and is included in one NDA. It is available from three suppliers. Additional details are available on the AMIDATE profile page.
The generic ingredient in AMIDATE is etomidate. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the etomidate profile page.
The generic ingredient in AMIDATE is etomidate. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the etomidate profile page.
Summary for 018227
| Tradename: | AMIDATE |
| Applicant: | Hospira |
| Ingredient: | etomidate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018227
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 018227
Suppliers and Packaging for NDA: 018227
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMIDATE | etomidate | INJECTABLE;INJECTION | 018227 | NDA | Henry Schein, Inc. | 0404-9811 | 0404-9811-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9811-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| AMIDATE | etomidate | INJECTABLE;INJECTION | 018227 | NDA | Hospira, Inc. | 0409-6695 | 0409-6695-01 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-6695-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Sep 7, 1982 | TE: | AP | RLD: | Yes | ||||
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