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 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. Six suppliers are listed for this compound. 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. Six suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
Pharmacology for NDA: 018243
| Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
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: | 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: | Jan 10, 2007 | TE: | AP | RLD: | Yes | ||||
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