Details for New Drug Application (NDA): 020592
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The generic ingredient in ZYPREXA is olanzapine pamoate. There are thirty-three 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 020592
Tradename: | ZYPREXA |
Applicant: | Cheplapharm |
Ingredient: | olanzapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 020592
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZYPREXA | olanzapine | TABLET;ORAL | 020592 | NDA | H2-Pharma LLC | 61269-630 | 61269-630-30 | 30 TABLET in 1 BOTTLE (61269-630-30) |
ZYPREXA | olanzapine | TABLET;ORAL | 020592 | NDA | H2-Pharma LLC | 61269-631 | 61269-631-30 | 30 TABLET in 1 BOTTLE (61269-631-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Sep 30, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 30, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Sep 30, 1996 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020592
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-005 | Sep 9, 1997 | 5,817,655*PED | ⤷ Subscribe |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-003 | Sep 30, 1996 | 5,736,541*PED | ⤷ Subscribe |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-005 | Sep 9, 1997 | 5,736,541*PED | ⤷ Subscribe |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-005 | Sep 9, 1997 | 5,817,656*PED | ⤷ Subscribe |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-005 | Sep 9, 1997 | 6,960,577 | ⤷ Subscribe |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-001 | Sep 30, 1996 | 6,960,577 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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