Details for New Drug Application (NDA): 018261
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The generic ingredient in PITOCIN is oxytocin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
Summary for 018261
Tradename: | PITOCIN |
Applicant: | Endo Operations |
Ingredient: | oxytocin |
Patents: | 0 |
Pharmacology for NDA: 018261
Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
Medical Subject Heading (MeSH) Categories for 018261
Suppliers and Packaging for NDA: 018261
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PITOCIN | oxytocin | INJECTABLE;INJECTION | 018261 | NDA | Endo USA, Inc. | 42023-116 | 42023-116-73 | 25 VIAL in 1 CARTON (42023-116-73) / 10 mL in 1 VIAL |
PITOCIN | oxytocin | INJECTABLE;INJECTION | 018261 | NDA | Endo USA, Inc. | 42023-116 | 42023-116-83 | 25 VIAL in 1 CARTON (42023-116-83) / 1 mL in 1 VIAL |
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: | Jul 27, 2007 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500USP UNITS/50ML (10USP UNITS/ML) | ||||
Approval Date: | Sep 5, 2012 | TE: | RLD: | Yes |
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