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Last Updated: October 5, 2024

Details for New Drug Application (NDA): 018243


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NDA 018243 describes OXYTOCIN, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Sagent Pharms Inc, and Abbott, and is included in six NDAs. It is available from four suppliers. Additional details are available on the OXYTOCIN profile page.

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 018243
Tradename:OXYTOCIN
Applicant:Hikma
Ingredient:oxytocin
Patents:0
Pharmacology for NDA: 018243
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:RXDosage:INJECTABLE;INJECTIONStrength10USP UNITS/ML (10USP UNITS/ML)
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100USP UNITS/10ML (10USP UNITS/ML)
Approval Date:Jan 10, 2007TE:APRLD:Yes

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