Details for New Drug Application (NDA): 203856
✉ Email this page to a colleague
NDA 203856 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Alembic, Ani Pharms, Cipla, Hikma, Kanchan Hlthcare, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Sandoz, and Roxane, and is included in twenty-three NDAs. It is available from twenty-four suppliers. There are four patents protecting this drug. Additional details are available on the CYCLOPHOSPHAMIDE profile page.
The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 203856
| Tradename: | CYCLOPHOSPHAMIDE |
| Applicant: | Hikma |
| Ingredient: | cyclophosphamide |
| Patents: | 0 |
Pharmacology for NDA: 203856
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 203856
Suppliers and Packaging for NDA: 203856
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | cyclophosphamide | CAPSULE;ORAL | 203856 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0382 | 0054-0382-25 | 100 CAPSULE in 1 BOTTLE (0054-0382-25) |
| CYCLOPHOSPHAMIDE | cyclophosphamide | CAPSULE;ORAL | 203856 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-0383 | 0054-0383-25 | 100 CAPSULE in 1 BOTTLE (0054-0383-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 16, 2013 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 16, 2013 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
