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FDA ANDA · ANDA207583

TESTOSTERONE UNDECANOATE

Sponsor: HIKMA PHARMACEUTICALS USA INC

APPLICATION
ANDA207583
TYPE
ANDA
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)

Products

TESTOSTERONE UNDECANOATENone (Tentative Approval)
TESTOSTERONE UNDECANOATE 750MG/3ML (250MG/ML) · INJECTABLE · INTRAMUSCULAR

Approval history

2016-12-09UNKNOWN · Original · standardTA
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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