Details for New Drug Application (NDA): 200752
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NDA 200752 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland, and Hikma, and is included in three NDAs. It is available from six 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 200752
| Tradename: | DEXRAZOXANE HYDROCHLORIDE |
| Applicant: | Eugia Pharma |
| Ingredient: | dexrazoxane hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 200752
Suppliers and Packaging for NDA: 200752
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 200752 | ANDA | AuroMedics Pharma LLC | 55150-434 | 55150-434-02 | 1 KIT in 1 PACKAGE (55150-434-02) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02) * 25 mL in 1 VIAL (55150-433-02) |
| DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 200752 | ANDA | AuroMedics Pharma LLC | 55150-434 | 55150-434-01 | 1 KIT in 1 PACKAGE (55150-434-01) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-01) * 25 mL in 1 VIAL (55150-433-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Oct 19, 2011 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Oct 19, 2011 | TE: | AP | RLD: | No | ||||
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