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PITOCIN (nda018261)- (10USP UNITS/ML (10USP UNITS/ML),100USP UNITS/10ML (10USP UNITS/ML),500USP UNITS/50ML (10USP UNITS/ML))

OXYTOCIN ENDO OPERATIONS
10USP UNITS/ML (10USP UNITS/ML),100USP UNITS/10ML (10USP UNITS/ML),500USP UNITS/50ML (10USP UNITS/ML)
No No
Expired Expired
None None
None No
* Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. * Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
0 0 0
Total Other Developers 3
Drugs with Suitability No
10USP UNITS/ML (10USP UNITS/ML) ** ** - - -
100USP UNITS/10ML (10USP UNITS/ML) ** ** - - -
500USP UNITS/50ML (10USP UNITS/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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