Details for New Drug Application (NDA): 203802
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NDA 203802 describes PALIPERIDONE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Teva Pharms Usa, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the PALIPERIDONE profile page.
The generic ingredient in PALIPERIDONE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
The generic ingredient in PALIPERIDONE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 203802
| Tradename: | PALIPERIDONE |
| Applicant: | Rk Pharma |
| Ingredient: | paliperidone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203802
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 203802 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3980 | 0378-3980-93 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3980-93) |
| PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 203802 | ANDA | REMEDYREPACK INC. | 70518-3873 | 70518-3873-0 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-3873-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Sep 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3MG | ||||
| Approval Date: | Sep 24, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
| Approval Date: | Sep 24, 2015 | TE: | AB | RLD: | No | ||||
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