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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040342
Company: VISTAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription AB No No
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
01/31/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40342ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/02/2021 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/02/2021 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/02/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/02/2021 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/02/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/15/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/15/2014 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/15/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/26/2010 SUPPL-5 Labeling-Package Insert

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 VIATRIS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040420 PAI HOLDINGS PHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040521 TARO
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040342 VISTAPHARM

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 VIATRIS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040420 PAI HOLDINGS PHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040521 TARO
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040342 VISTAPHARM
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