Details for New Drug Application (NDA): 021086
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NDA 021086 describes ZYPREXA ZYDIS, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from one supplier. Additional details are available on the ZYPREXA ZYDIS profile page.
The generic ingredient in ZYPREXA ZYDIS is olanzapine. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the olanzapine profile page.
The generic ingredient in ZYPREXA ZYDIS is olanzapine. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the olanzapine profile page.
Summary for 021086
| Tradename: | ZYPREXA ZYDIS |
| Applicant: | Cheplapharm |
| Ingredient: | olanzapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086 | NDA | H2-Pharma LLC | 61269-650 | 61269-650-35 | 30 DOSE PACK in 1 CARTON (61269-650-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-650-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086 | NDA | H2-Pharma LLC | 61269-651 | 61269-651-35 | 30 DOSE PACK in 1 CARTON (61269-651-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-651-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 6, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 6, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | Apr 6, 2000 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021086
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-003 | Apr 6, 2000 | 5,627,178 | ⤷ Subscribe |
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-001 | Apr 6, 2000 | 6,960,577 | ⤷ Subscribe |
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-002 | Apr 6, 2000 | 5,817,656 | ⤷ Subscribe |
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-004 | Apr 6, 2000 | 5,605,897 | ⤷ Subscribe |
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-004 | Apr 6, 2000 | 5,817,656 | ⤷ Subscribe |
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-003 | Apr 6, 2000 | 5,457,895 | ⤷ Subscribe |
| Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-003 | Apr 6, 2000 | 5,736,541 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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