Details for New Drug Application (NDA): 215028
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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.
Pharmacology for NDA: 215028
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 215028
Suppliers and Packaging for NDA: 215028
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETOMIDATE | etomidate | INJECTABLE;INJECTION | 215028 | ANDA | Caplin Steriles Limited | 65145-127 | 65145-127-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (65145-127-01) |
ETOMIDATE | etomidate | INJECTABLE;INJECTION | 215028 | ANDA | Caplin Steriles Limited | 65145-128 | 65145-128-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-128-10) / 20 mL in 1 VIAL, SINGLE-DOSE (65145-128-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Dec 18, 2020 | TE: | AP | RLD: | No |
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