Details for New Drug Application (NDA): 208820
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NDA 208820 describes PRAZIQUANTEL, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the PRAZIQUANTEL profile page.
The generic ingredient in PRAZIQUANTEL is praziquantel. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the praziquantel profile page.
The generic ingredient in PRAZIQUANTEL is praziquantel. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the praziquantel profile page.
Summary for 208820
| Tradename: | PRAZIQUANTEL |
| Applicant: | Endo Operations |
| Ingredient: | praziquantel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208820
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAZIQUANTEL | praziquantel | TABLET;ORAL | 208820 | ANDA | Endo USA, Inc. | 49884-231 | 49884-231-83 | 6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Nov 27, 2017 | TE: | RLD: | No | |||||
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