Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040646
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription AB No No
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription AB No No
HYDROCORTISONE HYDROCORTISONE 20MG 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
03/30/2007 ORIG-1 Approval

Label is not available on this site.

HYDROCORTISONE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTEF HYDROCORTISONE 5MG TABLET;ORAL Prescription Yes AB 008697 PHARMACIA AND UPJOHN
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 207029 BRECKENRIDGE
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 083365 HIKMA INTL PHARMS
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 040646 IMPAX LABS INC
HYDROCORTISONE HYDROCORTISONE 5MG TABLET;ORAL Prescription No AB 040761 VINTAGE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTEF HYDROCORTISONE 10MG TABLET;ORAL Prescription Yes AB 008697 PHARMACIA AND UPJOHN
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 207029 BRECKENRIDGE
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 083365 HIKMA INTL PHARMS
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 040646 IMPAX LABS INC
HYDROCORTISONE HYDROCORTISONE 10MG TABLET;ORAL Prescription No AB 040761 VINTAGE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORTEF HYDROCORTISONE 20MG TABLET;ORAL Prescription Yes AB 008697 PHARMACIA AND UPJOHN
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 207029 BRECKENRIDGE
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 083365 HIKMA INTL PHARMS
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 040646 IMPAX LABS INC
HYDROCORTISONE HYDROCORTISONE 20MG TABLET;ORAL Prescription No AB 040761 VINTAGE

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