Details for New Drug Application (NDA): 018248
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The generic ingredient in OXYTOCIN is oxytocin. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
Summary for 018248
Tradename: | OXYTOCIN |
Applicant: | Fresenius Kabi Usa |
Ingredient: | oxytocin |
Patents: | 0 |
Pharmacology for NDA: 018248
Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
Medical Subject Heading (MeSH) Categories for 018248
Suppliers and Packaging for NDA: 018248
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYTOCIN | oxytocin | INJECTABLE;INJECTION | 018248 | NDA | Cardinal Health 107, LLC | 55154-9584 | 55154-9584-5 | 5 VIAL in 1 BAG (55154-9584-5) / 1 mL in 1 VIAL |
OXYTOCIN | oxytocin | INJECTABLE;INJECTION | 018248 | NDA | Fresenius Kabi USA, LLC | 63323-012 | 63323-012-07 | 25 VIAL in 1 TRAY (63323-012-07) / 1 mL in 1 VIAL (63323-012-17) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10USP UNITS/ML (10USP UNITS/ML) | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100USP UNITS/10ML (10USP UNITS/ML) | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300USP UNITS/30ML (10USP UNITS/ML) | ||||
Approval Date: | Jul 27, 2007 | TE: | RLD: | Yes |
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