Details for New Drug Application (NDA): 203619
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NDA 203619 describes PENTOBARBITAL SODIUM, which is a drug marketed by Lannett, Vitarine, Whiteworth Town Plsn, Bpi Labs, Elkins Sinn, Hikma, and Sagent Pharms Inc, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the PENTOBARBITAL SODIUM profile page.
The generic ingredient in PENTOBARBITAL 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 PENTOBARBITAL 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 203619
| Tradename: | PENTOBARBITAL SODIUM |
| Applicant: | Hikma |
| Ingredient: | pentobarbital sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTOBARBITAL SODIUM | pentobarbital sodium | INJECTABLE;INJECTION | 203619 | ANDA | Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | 24201-010 | 24201-010-20 | 1 VIAL in 1 CARTON (24201-010-20) / 20 mL in 1 VIAL |
| PENTOBARBITAL SODIUM | pentobarbital sodium | INJECTABLE;INJECTION | 203619 | ANDA | Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | 24201-010 | 24201-010-50 | 1 VIAL in 1 CARTON (24201-010-50) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Nov 13, 2017 | TE: | AP | RLD: | No | ||||
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