Details for New Drug Application (NDA): 209058
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NDA 209058 describes ETOMIDATE, which is a drug marketed by Avet Lifesciences, Caplin, Endo Operations, Eugia Pharma, Gland Pharma Ltd, Hikma, Luitpold, Mylan Labs Ltd, Rising, and Zydus Pharms, and is included in eleven NDAs. It is available from twelve 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the etomidate profile page.
Summary for 209058
| Tradename: | ETOMIDATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | etomidate |
| Patents: | 0 |
Pharmacology for NDA: 209058
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 209058
Suppliers and Packaging for NDA: 209058
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETOMIDATE | etomidate | INJECTABLE;INJECTION | 209058 | ANDA | Gland Pharma Limited | 68083-234 | 68083-234-10 | 10 VIAL in 1 CARTON (68083-234-10) / 10 mL in 1 VIAL (68083-234-01) |
| ETOMIDATE | etomidate | INJECTABLE;INJECTION | 209058 | ANDA | Gland Pharma Limited | 68083-235 | 68083-235-10 | 10 VIAL in 1 CARTON (68083-235-10) / 20 mL in 1 VIAL (68083-235-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Apr 18, 2017 | TE: | AP | RLD: | No | ||||
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