Details for New Drug Application (NDA): 203708
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NDA 203708 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-three 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 203708
| Tradename: | OLANZAPINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | olanzapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203708
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 203708 | ANDA | Aurobindo Pharma Limited | 65862-656 | 65862-656-03 | 3 BLISTER PACK in 1 CARTON (65862-656-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-656-10) |
| OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 203708 | ANDA | Aurobindo Pharma Limited | 65862-657 | 65862-657-03 | 3 BLISTER PACK in 1 CARTON (65862-657-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-657-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
| Approval Date: | May 15, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | May 15, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | May 15, 2014 | TE: | AB | RLD: | No | ||||
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