Details for New Drug Application (NDA): 204476
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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 204476
Tradename: | PRIMAQUINE PHOSPHATE |
Applicant: | Bayshore Pharms Llc |
Ingredient: | primaquine phosphate |
Patents: | 0 |
Suppliers and Packaging for NDA: 204476
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 204476 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-721 | 43063-721-14 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14) |
PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 204476 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-721 | 43063-721-28 | 28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
Approval Date: | Feb 25, 2014 | TE: | AB | RLD: | No |
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