Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040420
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN PHENYTOIN 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
04/19/2002 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40420ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040420_PhenytoinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

04/20/2005 SUPPL-5 Labeling

Label is not available on this site.

12/09/2003 SUPPL-4 Labeling

Label is not available on this site.

11/06/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/2002 SUPPL-2 Labeling

Label is not available on this site.

09/26/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

PHENYTOIN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN-125 PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription Yes AB 008762 PARKE DAVIS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040521 TARO
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040342 VISTAPHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040610 VISTAPHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040420 WOCKHARDT BIO AG

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