Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083976
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTRED METHYLTESTOSTERONE 10MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/03/1973 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-32 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/083976s032lbl.pdf
06/19/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/083976s031lbl.pdf
11/27/2002 SUPPL-27 Labeling

Label is not available on this site.

08/18/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/25/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/25/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/08/1994 SUPPL-23 Labeling

Label is not available on this site.

11/03/1992 SUPPL-22 Labeling

Label is not available on this site.

05/29/1992 SUPPL-21 Labeling

Label is not available on this site.

05/25/1989 SUPPL-20 Labeling

Label is not available on this site.

03/08/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2015 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/083976s032lbl.pdf
06/19/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/083976s031lbl.pdf

TESTRED

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLTESTOSTERONE METHYLTESTOSTERONE 10MG CAPSULE;ORAL Prescription No AB 204851 IMPAX LABS INC
TESTRED METHYLTESTOSTERONE 10MG CAPSULE;ORAL Prescription No AB 083976 VALEANT PHARM INTL

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