Details for New Drug Application (NDA): 204652
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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 204652
Tradename: | FLUCYTOSINE |
Applicant: | Novel Labs Inc |
Ingredient: | flucytosine |
Patents: | 0 |
Suppliers and Packaging for NDA: 204652
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 204652 | ANDA | Major Pharmaceuticals | 0904-6834 | 0904-6834-07 | 30 BLISTER PACK in 1 CARTON (0904-6834-07) / 1 CAPSULE in 1 BLISTER PACK |
FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 204652 | ANDA | Major Pharmaceuticals | 0904-6835 | 0904-6835-07 | 30 BLISTER PACK in 1 CARTON (0904-6835-07) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Jul 7, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 7, 2017 | TE: | AB | RLD: | No |
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