Details for New Drug Application (NDA): 078400
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NDA 078400 describes BUTORPHANOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apotex, and Rising, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the BUTORPHANOL TARTRATE profile page.
The generic ingredient in BUTORPHANOL TARTRATE is butorphanol tartrate. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
The generic ingredient in BUTORPHANOL TARTRATE is butorphanol tartrate. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
Summary for 078400
| Tradename: | BUTORPHANOL TARTRATE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | butorphanol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 078400
| Mechanism of Action | Competitive Opioid Antagonists Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 078400
Suppliers and Packaging for NDA: 078400
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | butorphanol tartrate | INJECTABLE;INJECTION | 078400 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9864 | 0143-9864-10 | 1 mL in 1 VIAL, SINGLE-DOSE (0143-9864-10) |
| BUTORPHANOL TARTRATE | butorphanol tartrate | INJECTABLE;INJECTION | 078400 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9867 | 0143-9867-10 | 1 mL in 1 VIAL, SINGLE-DOSE (0143-9867-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | May 1, 2009 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | May 1, 2009 | TE: | AP | RLD: | No | ||||
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