Details for New Drug Application (NDA): 018243
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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.
Pharmacology for NDA: 018243
Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
Medical Subject Heading (MeSH) Categories for 018243
Suppliers and Packaging for NDA: 018243
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYTOCIN | oxytocin | INJECTABLE;INJECTION | 018243 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6114 | 0641-6114-25 | 25 VIAL in 1 CARTON (0641-6114-25) / 1 mL in 1 VIAL (0641-6114-01) |
OXYTOCIN | oxytocin | INJECTABLE;INJECTION | 018243 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6115 | 0641-6115-25 | 25 VIAL in 1 CARTON (0641-6115-25) / 10 mL in 1 VIAL (0641-6115-01) |
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: | Jan 10, 2007 | TE: | AP | RLD: | Yes |
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