Details for New Drug Application (NDA): 206644
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NDA 206644 describes PLERIXAFOR, which is a drug marketed by Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the PLERIXAFOR profile page.
The generic ingredient in PLERIXAFOR is plerixafor. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the plerixafor profile page.
The generic ingredient in PLERIXAFOR is plerixafor. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the plerixafor profile page.
Summary for 206644
| Tradename: | PLERIXAFOR |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | plerixafor |
| Patents: | 0 |
Pharmacology for NDA: 206644
| Physiological Effect | Increased Hematopoietic Stem Cell Mobilization |
Suppliers and Packaging for NDA: 206644
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 206644 | ANDA | Sagent Pharmaceuticals | 25021-416 | 25021-416-01 | 1 VIAL in 1 CARTON (25021-416-01) / 1.2 mL in 1 VIAL |
| PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 206644 | ANDA | Gland Pharma Limited | 68083-155 | 68083-155-01 | 1 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 24MG/1.2ML (20MG/ML) | ||||
| Approval Date: | May 3, 2024 | TE: | AP | RLD: | No | ||||
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