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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207373
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL 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
04/10/2019 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

TESTOSTERONE

GEL, METERED;TRANSDERMAL; 1.62% (20.25MG/1.25GM ACTUATION)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription Yes AB 022309 BESINS HLTHCARE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 204570 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 207373 AMNEAL
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 208620 ENCUBE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 208560 LUPIN
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 204268 PADAGIS ISRAEL
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 210835 XIROMED
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