FDA ANDA · ANDA203846

METHAMPHETAMINE HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION

ANDA203846

TYPE

ANDA

ORIGINAL APPROVAL

2015-11-17

LATEST ACTION

2025-03-28

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

METHAMPHETAMINE HYDROCHLORIDEPrescription

METHAMPHETAMINE HYDROCHLORIDE 5MG · TABLET · ORAL

2025-03-28Manufacturing (CMC) · Supplement 9 · unknownAP

2024-04-18Labeling · Supplement 3 · standardAP

2024-04-18Labeling · Supplement 1 · standardAP

2024-04-18Labeling · Supplement 6 · standardAP

2024-04-18Labeling · Supplement 4 · standardAP

2024-04-18Labeling · Supplement 2 · standardAP

2015-11-17UNKNOWN · OriginalAP

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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