Details for New Drug Application (NDA): 208980
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NDA 208980 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 208980
| Tradename: | PLERIXAFOR |
| Applicant: | Zydus Pharms |
| Ingredient: | plerixafor |
| Patents: | 0 |
Pharmacology for NDA: 208980
| Physiological Effect | Increased Hematopoietic Stem Cell Mobilization |
Suppliers and Packaging for NDA: 208980
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 208980 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1208 | 70710-1208-1 | 1 VIAL, SINGLE-USE in 1 CARTON (70710-1208-1) / 1.2 mL in 1 VIAL, SINGLE-USE |
| PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 208980 | ANDA | Zydus Lifesciences Limited | 70771-1776 | 70771-1776-1 | 1 VIAL, SINGLE-USE in 1 CARTON (70771-1776-1) / 1.2 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 24MG/1.2ML (20MG/ML) | ||||
| Approval Date: | Jul 26, 2023 | TE: | RLD: | No | |||||
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