Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091244
Company: HIKMA FARMACEUTICA
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
05/01/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091244Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

07/22/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/19/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/26/2016 SUPPL-2

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 207742 AM REGENT
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 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
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 206368 WILSHIRE PHARMS INC

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