Details for New Drug Application (NDA): 006002
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NDA 006002 describes ARALEN, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. Additional details are available on the ARALEN profile page.
The generic ingredient in ARALEN is chloroquine phosphate; primaquine phosphate. There are twenty drug master file entries for this compound. Additional details are available on the chloroquine phosphate; primaquine phosphate profile page.
The generic ingredient in ARALEN is chloroquine phosphate; primaquine phosphate. There are twenty drug master file entries for this compound. Additional details are available on the chloroquine phosphate; primaquine phosphate profile page.
Summary for 006002
| Tradename: | ARALEN |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | chloroquine phosphate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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