Details for New Drug Application (NDA): 210852
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NDA 210852 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 210852
| Tradename: | CYCLOPHOSPHAMIDE |
| Applicant: | Avyxa Holdings |
| Ingredient: | cyclophosphamide |
| Patents: | 2 |
Medical Subject Heading (MeSH) Categories for 210852
Suppliers and Packaging for NDA: 210852
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 210852 | NDA | Avyxa Pharma, LLC | 83831-116 | 83831-116-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 210852 | NDA | Avyxa Pharma, LLC | 83831-117 | 83831-117-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-117-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/ML (500MG/ML) | ||||
| Approval Date: | Jun 7, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 1, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/2ML (500MG/ML) | ||||
| Approval Date: | Jun 7, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 13, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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