Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090094
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIDANOSINE DIDANOSINE 125MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
DIDANOSINE DIDANOSINE 200MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
DIDANOSINE DIDANOSINE 250MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
DIDANOSINE DIDANOSINE 400MG CAPSULE, DELAYED REL PELLETS;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
09/24/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090094_PEPFAR_APLetter.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/31/2012 SUPPL-9 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

12/27/2011 SUPPL-8 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

03/22/2010 SUPPL-6 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

09/02/2009 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/14/2008 SUPPL-1 Labeling

Label is not available on this site.

DIDANOSINE

CAPSULE, DELAYED REL PELLETS;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 125MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 125MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

CAPSULE, DELAYED REL PELLETS;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 200MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 200MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

CAPSULE, DELAYED REL PELLETS;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 250MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 250MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

CAPSULE, DELAYED REL PELLETS;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIDANOSINE DIDANOSINE 400MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090094 AUROBINDO PHARMA
VIDEX EC DIDANOSINE 400MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021183 BRISTOL MYERS SQUIBB

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