Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076268
Company: STEVENS J
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription AB No No
DIGOXIN DIGOXIN 0.25MG 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
07/26/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76268_Digoxin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076268_digoxin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2007 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf

DIGOXIN

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 077002 HIKMA INTL PHARMS
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 078556 IMPAX LABS
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 040282 MYLAN PHARMS INC
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 076268 STEVENS J
DIGOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription No AB 076363 SUN PHARM INDS INC
LANOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription Yes AB 020405 CONCORDIA

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 077002 HIKMA INTL PHARMS
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 078556 IMPAX LABS
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 040282 MYLAN PHARMS INC
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 076268 STEVENS J
DIGOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription No AB 076363 SUN PHARM INDS INC
LANOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription Yes AB 020405 CONCORDIA

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