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Details for New Drug Application (NDA): 202482

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NDA 202482 describes GRISEOFULVIN, which is a drug marketed by Perrigo Co Tennessee, Vintage Pharms, Cipla Ltd, Sigmapharm Labs Llc, Sandoz Inc, Actavis Mid Atlantic, and Riconpharma Llc, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the GRISEOFULVIN profile page.

The generic ingredient in GRISEOFULVIN 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: 202482

Tradename:
GRISEOFULVIN
Applicant:
Sigmapharm Labs Llc
Ingredient:
griseofulvin, microsize
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202482

Suppliers and Packaging for NDA: 202482

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRISEOFULVIN
griseofulvin, microsize
TABLET;ORAL 202482 ANDA Rising Pharmaceuticals Inc. 64980-186 64980-186-01 100 TABLET in 1 BOTTLE (64980-186-01)
GRISEOFULVIN
griseofulvin, microsize
TABLET;ORAL 202482 ANDA Rising Pharmaceuticals Inc. 64980-186 64980-186-03 30 TABLET in 1 BOTTLE (64980-186-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 22, 2012TE:ABRLD: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.

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