Details for New Drug Application (NDA): 210046
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NDA 210046 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Alembic, Ani Pharms, Cipla, Eirgen, Hikma, Senores Pharms, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane, and is included in twenty-six NDAs. It is available from twenty-three suppliers. There are three 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 210046
| Tradename: | CYCLOPHOSPHAMIDE |
| Applicant: | Amneal |
| Ingredient: | cyclophosphamide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210046
Suppliers and Packaging for NDA: 210046
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 210046 | ANDA | Amneal Pharmaceuticals LLC | 70121-1238 | 70121-1238-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1238-1) / 25 mL in 1 VIAL, SINGLE-DOSE |
| CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 210046 | ANDA | Amneal Pharmaceuticals LLC | 70121-1239 | 70121-1239-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1239-1) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | May 25, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | May 25, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | May 25, 2018 | TE: | AP | RLD: | No | ||||
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