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Details for New Drug Application (NDA): 204371

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NDA 204371 describes GRISEOFULVIN, ULTRAMICROSIZE, which is a drug marketed by Riconpharma Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the GRISEOFULVIN, ULTRAMICROSIZE profile page.

The generic ingredient in GRISEOFULVIN, ULTRAMICROSIZE is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

Summary for NDA: 204371

Tradename:
GRISEOFULVIN, ULTRAMICROSIZE
Applicant:
Riconpharma Llc
Ingredient:
griseofulvin, ultramicrosize
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204371

Suppliers and Packaging for NDA: 204371

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN, ULTRAMICROSIZE
griseofulvin, ultramicrosize
TABLET;ORAL 204371 ANDA RiconPharma LLC. 51125-005 51125-005-06 100 TABLET, COATED in 1 BOTTLE, PLASTIC (51125-005-06)
GRISEOFULVIN, ULTRAMICROSIZE
griseofulvin, ultramicrosize
TABLET;ORAL 204371 ANDA RiconPharma LLC. 51125-005 51125-005-08 500 TABLET, COATED in 1 BOTTLE, PLASTIC (51125-005-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Jan 9, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 9, 2014TE:ABRLD:No


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