Details for New Drug Application (NDA): 206043
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NDA 206043 describes PRIMAQUINE PHOSPHATE, which is a drug marketed by Alvogen, Bayshore Pharms Llc, and Novast Labs, and is included in three NDAs. It is available from five suppliers. Additional details are available on the PRIMAQUINE PHOSPHATE profile page.
The generic ingredient in PRIMAQUINE PHOSPHATE is primaquine phosphate. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the primaquine phosphate profile page.
The generic ingredient in PRIMAQUINE PHOSPHATE is primaquine phosphate. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the primaquine phosphate profile page.
Summary for 206043
| Tradename: | PRIMAQUINE PHOSPHATE |
| Applicant: | Novast Labs |
| Ingredient: | primaquine phosphate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206043
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 206043 | ANDA | AvKARE | 42291-510 | 42291-510-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01) |
| PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 206043 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-191 | 50742-191-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Jun 23, 2016 | TE: | AB | RLD: | No | ||||
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