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Details for New Drug Application (NDA): 062483

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NDA 062483 describes GRIFULVIN V, which is a drug marketed by J And J, Johnson And Johnson, and Valeant Luxembourg, and is included in four NDAs. It is available from one supplier. Additional details are available on the GRIFULVIN V profile page.

The generic ingredient in GRIFULVIN V is griseofulvin, microsize. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the griseofulvin, microsize profile page.

Summary for NDA: 062483

Valeant Luxembourg
griseofulvin, microsize

Pharmacology for NDA: 062483

Suppliers and Packaging for NDA: 062483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
griseofulvin, microsize
SUSPENSION;ORAL 062483 ANDA Physicians Total Care, Inc. 54868-5234 54868-5234-0 120 mL in 1 BOTTLE (54868-5234-0)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 26, 1984TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.