Details for New Drug Application (NDA): 212632
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The generic ingredient in FLUCYTOSINE is flucytosine. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the flucytosine profile page.
Summary for 212632
Tradename: | FLUCYTOSINE |
Applicant: | Strides Pharma |
Ingredient: | flucytosine |
Patents: | 0 |
Suppliers and Packaging for NDA: 212632
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 212632 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-860 | 23155-860-01 | 100 CAPSULE in 1 BOTTLE (23155-860-01) |
FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 212632 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-860 | 23155-860-03 | 30 CAPSULE in 1 BOTTLE (23155-860-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Apr 17, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 17, 2020 | TE: | AB | RLD: | No |
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