Details for New Drug Application (NDA): 200219
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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 200219
Tradename: | OXYTOCIN |
Applicant: | Hikma Farmaceutica |
Ingredient: | oxytocin |
Patents: | 0 |
Pharmacology for NDA: 200219
Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
Medical Subject Heading (MeSH) Categories for 200219
Suppliers and Packaging for NDA: 200219
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYTOCIN | oxytocin | INJECTABLE;INJECTION | 200219 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9742 | 0143-9742-25 | 25 VIAL in 1 CARTON (0143-9742-25) / 10 mL in 1 VIAL (0143-9742-01) |
OXYTOCIN | oxytocin | INJECTABLE;INJECTION | 200219 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9743 | 0143-9743-25 | 25 VIAL in 1 CARTON (0143-9743-25) / 1 mL in 1 VIAL (0143-9743-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10USP UNITS/ML (10USP UNITS/ML) | ||||
Approval Date: | Feb 13, 2013 | TE: | AP | RLD: | No |
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