Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040401
Company: HI TECH PHARMA CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/27/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/29/2009 SUPPL-2 Labeling

Label is not available on this site.

PREDNISOLONE

SYRUP;ORAL; 15MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040401 HI TECH PHARMA CO
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040775 LANNETT CO INC
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040399 PHARM ASSOC
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040323 VISTAPHARM
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040313 WOCKHARDT BIO AG
PRELONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 089081 TEVA

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