Details for New Drug Application (NDA): 215089
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NDA 215089 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 215089
| Tradename: | CYCLOPHOSPHAMIDE |
| Applicant: | Sunny |
| Ingredient: | cyclophosphamide |
| Patents: | 0 |
Pharmacology for NDA: 215089
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 215089
Suppliers and Packaging for NDA: 215089
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 215089 | ANDA | Long Grove Pharmaceuticals, LLC | 81298-8110 | 81298-8110-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-8110-1) / 25 mL in 1 VIAL, SINGLE-DOSE |
| CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 215089 | ANDA | Long Grove Pharmaceuticals, LLC | 81298-8112 | 81298-8112-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-8112-1) / 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: | Oct 26, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Oct 26, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Oct 26, 2023 | TE: | AP | RLD: | No | ||||
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