APPLICATION
ANDA207368
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-22
LATEST ACTION
2021-02-18
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 10MG/ML · CONCENTRATE · ORAL
Approval history
2021-02-18Labeling · Supplement 2 · standardAP
2019-08-22UNKNOWN · 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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