Details for New Drug Application (NDA): 021253
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The generic ingredient in ZYPREXA is olanzapine pamoate. There are thirty-three drug master file entries for this compound. Two suppliers are 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 | INJECTABLE;INTRAMUSCULAR | 021253 | NDA | Eli Lilly and Company | 0002-7597 | 0002-7597-01 | 1 VIAL in 1 CARTON (0002-7597-01) / 2 mL in 1 VIAL |
| ZYPREXA | olanzapine | INJECTABLE;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: | INJECTABLE;INTRAMUSCULAR | Strength | 10MG/VIAL | ||||
| Approval Date: | Mar 29, 2004 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 021253
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cheplapharm | ZYPREXA | olanzapine | INJECTABLE;INTRAMUSCULAR | 021253-001 | Mar 29, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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