Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208061
Company: LUPIN LTD
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
10/23/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208061Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2019 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/10/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

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 208061 LUPIN LTD
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 204255 PERRIGO ISRAEL

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