Details for New Drug Application (NDA): 204319
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NDA 204319 describes OLANZAPINE, which is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Natco Pharma, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Endo Operations, and Epic Pharma Llc, and is included in forty-six NDAs. It is available from forty-five suppliers. Additional details are available on the OLANZAPINE profile page.
The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 204319
| Tradename: | OLANZAPINE |
| Applicant: | Qilu |
| Ingredient: | olanzapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204319
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | olanzapine | TABLET;ORAL | 204319 | ANDA | Upsher-Smith Laboratories, LLC | 0832-6078 | 0832-6078-03 | 30 TABLET in 1 BOTTLE (0832-6078-03) |
| OLANZAPINE | olanzapine | TABLET;ORAL | 204319 | ANDA | Upsher-Smith Laboratories, LLC | 0832-6078 | 0832-6078-50 | 500 TABLET in 1 BOTTLE (0832-6078-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No | ||||
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