Details for New Drug Application (NDA): 207321
✉ Email this page to a colleague
NDA 207321 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland, and Hikma, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the DEXRAZOXANE HYDROCHLORIDE profile page.
The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 207321
| Tradename: | DEXRAZOXANE HYDROCHLORIDE |
| Applicant: | Gland |
| Ingredient: | dexrazoxane hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207321
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 207321 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-942 | 51991-942-98 | 1 VIAL, SINGLE-DOSE in 1 CARTON (51991-942-98) / 50 mL in 1 VIAL, SINGLE-DOSE |
| DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 207321 | ANDA | Gland Pharma Limited | 68083-195 | 68083-195-01 | 1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Nov 28, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Dec 16, 2019 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
