Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209836
Company: TWI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription AT 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
09/03/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

TESTOSTERONE

SOLUTION, METERED;TRANSDERMAL; 30MG/1.5ML ACTUATION
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 205328 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 209533 CIPLA
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 212301 DASH PHARMS
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 208061 LUPIN LTD
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 204255 PADAGIS ISRAEL
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 209836 TWI PHARMS

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