Details for New Drug Application (NDA): 021253
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NDA 021253 describes ZYPREXA, which is a drug marketed by Cheplapharm and is included in four NDAs. It is available from one supplier. Additional details are available on the ZYPREXA profile page.
The generic ingredient in ZYPREXA is olanzapine pamoate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine pamoate profile page.
The generic ingredient in ZYPREXA is olanzapine pamoate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine pamoate profile page.
Summary for 021253
| Tradename: | ZYPREXA |
| Applicant: | Cheplapharm |
| Ingredient: | olanzapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021253
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYPREXA | olanzapine | POWDER;INTRAMUSCULAR | 021253 | NDA | H2-Pharma LLC | 61269-640 | 61269-640-20 | 1 VIAL in 1 CARTON (61269-640-20) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 10MG/VIAL | ||||
| Approval Date: | Mar 29, 2004 | TE: | AP | RLD: | Yes | ||||
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