Details for New Drug Application (NDA): 083246
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NDA 083246 describes NEMBUTAL SODIUM, which is a drug marketed by Epic Pharma Llc and Rising and is included in four NDAs. It is available from two suppliers. Additional details are available on the NEMBUTAL SODIUM profile page.
The generic ingredient in NEMBUTAL SODIUM is pentobarbital sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.
The generic ingredient in NEMBUTAL SODIUM is pentobarbital sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.
Summary for 083246
| Tradename: | NEMBUTAL SODIUM |
| Applicant: | Rising |
| Ingredient: | pentobarbital sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 083246
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEMBUTAL SODIUM | pentobarbital sodium | INJECTABLE;INJECTION | 083246 | ANDA | Akorn | 17478-181 | 17478-181-20 | 1 VIAL, MULTI-DOSE in 1 CARTON (17478-181-20) / 20 mL in 1 VIAL, MULTI-DOSE |
| NEMBUTAL SODIUM | pentobarbital sodium | INJECTABLE;INJECTION | 083246 | ANDA | Akron | 76478-501 | 76478-501-20 | 1 VIAL in 1 CARTON (76478-501-20) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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