Details for New Drug Application (NDA): 206126
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NDA 206126 describes ETOMIDATE, which is a drug marketed by Avet Lifesciences, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Luitpold, Mylan Labs Ltd, Par Sterile Products, Rising, and Zydus Pharms, and is included in eleven NDAs. It is available from thirteen suppliers. Additional details are available on the ETOMIDATE profile page.
The generic ingredient in ETOMIDATE 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 ETOMIDATE 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 206126
| Tradename: | ETOMIDATE |
| Applicant: | Eugia Pharma |
| Ingredient: | etomidate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206126
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 206126
Suppliers and Packaging for NDA: 206126
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETOMIDATE | etomidate | INJECTABLE;INJECTION | 206126 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1542 | 51662-1542-1 | 20 mL in 1 VIAL, SINGLE-DOSE (51662-1542-1) |
| ETOMIDATE | etomidate | INJECTABLE;INJECTION | 206126 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1634 | 51662-1634-1 | 10 mL in 1 VIAL, SINGLE-DOSE (51662-1634-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Feb 24, 2017 | TE: | AP | RLD: | No | ||||
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