Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065200
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION;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
03/02/2005 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065200_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2007 SUPPL-4 Labeling

Label is not available on this site.

GRISEOFULVIN

SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION;ORAL Prescription No AB 065394 ACTAVIS MID ATLANTIC
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION;ORAL Prescription No AB 065200 CHARTWELL RX
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION;ORAL Prescription No AB 065354 CIPLA
GRISEOFULVIN GRISEOFULVIN, MICROSIZE 125MG/5ML SUSPENSION;ORAL Prescription No AB 065438 VINTAGE PHARMS

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