Details for New Drug Application (NDA): 074626
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The generic ingredient in BUTORPHANOL TARTRATE PRESERVATIVE FREE 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 074626
Tradename: | BUTORPHANOL TARTRATE PRESERVATIVE FREE |
Applicant: | Hospira |
Ingredient: | butorphanol tartrate |
Patents: | 0 |
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 | 0409-1626-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21) |
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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