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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202482
Company: SIGMAPHARM LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 500MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/2012 ORIG-1 Approval

Label is not available on this site.

GRISEOFULVIN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FULVICIN-U/F GRISEOFULVIN, MICROSIZE 500MG TABLET;ORAL Prescription No AB 060569 CHARTWELL RX
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 500MG TABLET;ORAL Prescription No AB 091592 SANDOZ
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 500MG TABLET;ORAL Prescription No AB 202482 SIGMAPHARM LABS LLC
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