Details for New Drug Application (NDA): 011559
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NDA 011559 describes BREVITAL SODIUM, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the BREVITAL SODIUM profile page.
The generic ingredient in BREVITAL SODIUM is methohexital sodium. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methohexital sodium profile page.
The generic ingredient in BREVITAL SODIUM is methohexital sodium. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methohexital sodium profile page.
Summary for 011559
| Tradename: | BREVITAL SODIUM |
| Applicant: | Endo Operations |
| Ingredient: | methohexital sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 011559
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BREVITAL SODIUM | methohexital sodium | INJECTABLE;INJECTION | 011559 | NDA | Endo USA, Inc. | 42023-105 | 42023-105-01 | 1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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