Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090387
Company: WEST-WARD PHARMS INT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription AO No No
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
07/15/2010 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 085635 PHARMACIA AND UPJOHN
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 210362 CIPLA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 040615 SANDOZ INC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 201720 SUN PHARM INDS LTD
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 090387 WEST-WARD PHARMS INT

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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