Details for New Drug Application (NDA): 076068
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NDA 076068 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland, Hikma, and MSN, and is included in four 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 076068
| Tradename: | DEXRAZOXANE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | dexrazoxane hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076068
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 076068 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9247 | 0143-9247-01 | 1 VIAL in 1 BOX (0143-9247-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 076068 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9248 | 0143-9248-01 | 1 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Sep 28, 2004 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Sep 28, 2004 | TE: | AP | RLD: | No | ||||
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