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Details for New Drug Application (NDA): 074626
NDA 074626 describes BUTORPHANOL TARTRATE PRESERVATIVE FREE, which is a drug marketed by Baxter Hlthcare Corp, Hospira, and West-ward Pharms Int, and is included in five NDAs. It is available from one supplier. Additional details are available on the BUTORPHANOL TARTRATE PRESERVATIVE FREE profile page.
The generic ingredient in BUTORPHANOL TARTRATE PRESERVATIVE FREE is butorphanol tartrate. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
The generic ingredient in BUTORPHANOL TARTRATE PRESERVATIVE FREE is butorphanol tartrate. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
Summary for 074626
| Tradename: | BUTORPHANOL TARTRATE PRESERVATIVE FREE |
| Applicant: | Hospira |
| Ingredient: | butorphanol tartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074626
| Mechanism of Action | Competitive Opioid Antagonists Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 074626
Suppliers and Packaging for NDA: 074626
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 074626 | ANDA | Hospira, Inc. | 0409-1623 | 0409-1623-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1623-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-1623-21) |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 074626 | ANDA | Hospira, Inc. | 0409-1626 | 0409-1626-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Jan 23, 1997 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Jan 23, 1997 | TE: | AP | RLD: | No | ||||
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