Details for New Drug Application (NDA): 075499
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NDA 075499 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 075499
| Tradename: | BUTORPHANOL TARTRATE |
| Applicant: | Apotex |
| Ingredient: | butorphanol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 075499
| Mechanism of Action | Competitive Opioid Antagonists Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 075499
Suppliers and Packaging for NDA: 075499
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | butorphanol tartrate | SPRAY, METERED;NASAL | 075499 | ANDA | Apotex Corp. | 60505-0813 | 60505-0813-1 | 1 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) / 2.5 mL in 1 BOTTLE, SPRAY |
| BUTORPHANOL TARTRATE | butorphanol tartrate | SPRAY, METERED;NASAL | 075499 | ANDA | Bryant Ranch Prepack | 72162-2099 | 72162-2099-2 | 1 BOTTLE, SPRAY in 1 CONTAINER (72162-2099-2) / 2.5 mL in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 1MG/SPRAY | ||||
| Approval Date: | Dec 4, 2002 | TE: | AB | RLD: | No | ||||
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