APPLICATION
ANDA210214
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-22
LATEST ACTION
2023-09-18
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TREPROSTINILPrescription
TREPROSTINIL 5MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
TREPROSTINILPrescription
TREPROSTINIL 1MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
TREPROSTINILPrescription
TREPROSTINIL 10MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
TREPROSTINILPrescription
TREPROSTINIL 2.5MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
Approval history
2023-09-18Labeling · Supplement 4 · standardAP
2022-07-07Manufacturing (CMC) · Supplement 3 · unknownAP
2020-05-22UNKNOWN · Original · standardAP
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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