Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040282
Company: MYLAN PHARMS INC
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
12/23/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40282ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40282_Digoxin.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/28/2019 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

11/02/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/03/2014 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040282Orig1s013ltr.pdf
06/12/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/2001 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/07/2001 SUPPL-3 Labeling

Label is not available on this site.

10/31/2000 SUPPL-2 Labeling

Label is not available on this site.

02/07/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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 PHARMS INC

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 PHARMS INC

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