Details for New Drug Application (NDA): 212501
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NDA 212501 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, Nexus, Sandoz, and Roxane, and is included in twenty-four 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 212501
| Tradename: | CYCLOPHOSPHAMIDE |
| Applicant: | Dr Reddys |
| Ingredient: | cyclophosphamide |
| Patents: | 1 |
Pharmacology for NDA: 212501
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 212501
Suppliers and Packaging for NDA: 212501
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 212501 | NDA | Ingenus Pharmaceuticals, LLC | 50742-519 | 50742-519-02 | 1 VIAL in 1 CARTON (50742-519-02) / 2.5 mL in 1 VIAL |
| CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 212501 | NDA | Ingenus Pharmaceuticals, LLC | 50742-520 | 50742-520-05 | 1 VIAL in 1 CARTON (50742-520-05) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/2.5ML (200MG/ML) | ||||
| Approval Date: | Jul 30, 2020 | TE: | AP | RLD: | Yes | ||||
| Patent: | 10,993,952 | Patent Expiration: | Feb 15, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/5ML (200MG/ML) | ||||
| Approval Date: | Jul 30, 2020 | TE: | AP | RLD: | Yes | ||||
| Patent: | 10,993,952 | Patent Expiration: | Feb 15, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2GM/10ML (200MG/ML) | ||||
| Approval Date: | Nov 19, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 10,993,952 | Patent Expiration: | Feb 15, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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