Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207742
Company: LUITPOLD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription AO 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
06/16/2017 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
04/04/2018 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION; 200MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 085635 PHARMACIA AND UPJOHN
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 210362 CIPLA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 091244 HIKMA FARMACEUTICA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 207742 LUITPOLD
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040652 MYLAN INSTITUTIONAL
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040530 PADDOCK LLC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040615 SANDOZ INC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 201720 SUN PHARM INDS LTD
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 086030 WATSON PHARMS INC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 090387 WEST-WARD PHARMS INT

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