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Details for New Drug Application (NDA): 200219

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NDA 200219 describes OXYTOCIN, which is a drug marketed by Hikma Farmaceutica, West-ward Pharms Int, Fresenius Kabi Usa, Teva Pharms Usa, and Abbott, and is included in five NDAs. It is available from five 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. Eight suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

Summary for NDA: 200219

Tradename:
OXYTOCIN
Applicant:
Hikma Farmaceutica
Ingredient:
oxytocin
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Pharmaceutical 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 Pharmaceutical Corp 0143-9743 0143-9743-25 25 VIAL in 1 CARTON (0143-9743-25) > 1 mL in 1 VIAL (0143-9743-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10USP UNITS/ML (10USP UNITS/ML)
Approval Date:Feb 13, 2013TE:APRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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