Details for New Drug Application (NDA): 040516
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NDA 040516 describes CHLOROQUINE PHOSPHATE, which is a drug marketed by Hikma Pharms, Impax Labs, Ipca Labs Ltd, Md Pharm, Natco Pharma Ltd, Purepac Pharm, Suven Pharms, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the CHLOROQUINE PHOSPHATE profile page.
The generic ingredient in CHLOROQUINE PHOSPHATE is chloroquine phosphate. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the chloroquine phosphate profile page.
The generic ingredient in CHLOROQUINE PHOSPHATE is chloroquine phosphate. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the chloroquine phosphate profile page.
Summary for 040516
| Tradename: | CHLOROQUINE PHOSPHATE |
| Applicant: | Impax Labs |
| Ingredient: | chloroquine phosphate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 040516
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLOROQUINE PHOSPHATE | chloroquine phosphate | TABLET;ORAL | 040516 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-7010 | 0115-7010-01 | 100 TABLET in 1 BOTTLE (0115-7010-01) |
| CHLOROQUINE PHOSPHATE | chloroquine phosphate | TABLET;ORAL | 040516 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-7010 | 0115-7010-02 | 500 TABLET in 1 BOTTLE (0115-7010-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 29, 2003 | TE: | AA | RLD: | No | ||||
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