Details for New Drug Application (NDA): 200219
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NDA 200219 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.
Summary for 200219
| Tradename: | OXYTOCIN |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | oxytocin |
| Patents: | 0 |
Pharmacology for NDA: 200219
| Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
Medical Subject Heading (MeSH) Categories for 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 Pharmaceuticals 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 Pharmaceuticals Corp | 0143-9743 | 0143-9743-25 | 25 VIAL in 1 CARTON (0143-9743-25) / 1 mL in 1 VIAL (0143-9743-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10USP UNITS/ML (10USP UNITS/ML) | ||||
| Approval Date: | Feb 13, 2013 | TE: | AP | RLD: | No | ||||
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