Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078957
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription AB No No
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription AB No No
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription AB No No
STAVUDINE STAVUDINE 40MG CAPSULE;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
12/29/2008 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000_TA_PEPFAR_Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078957s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2015 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/02/2009 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

05/27/2009 SUPPL-1 Labeling

Label is not available on this site.

STAVUDINE

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 15MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 20MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 30MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Prescription No AB 077672 AUROBINDO PHARMA
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Prescription No AB 078957 HETERO LABS LTD III
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Prescription No AB 079069 MYLAN
ZERIT STAVUDINE 40MG CAPSULE;ORAL Prescription Yes AB 020412 BRISTOL MYERS SQUIBB

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