Details for New Drug Application (NDA): 203729
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The generic ingredient in QUININE SULFATE is quinine sulfate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.
Summary for 203729
Tradename: | QUININE SULFATE |
Applicant: | Amneal Pharms |
Ingredient: | quinine sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 203729
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203729 | ANDA | Amneal Pharmaceuticals LLC | 65162-811 | 65162-811-03 | 30 CAPSULE in 1 BOTTLE (65162-811-03) |
QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203729 | ANDA | Amneal Pharmaceuticals LLC | 65162-811 | 65162-811-09 | 90 CAPSULE in 1 BOTTLE (65162-811-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 324MG | ||||
Approval Date: | Jul 15, 2015 | TE: | AB | RLD: | No |
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