Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203846
Company: HIKMA

Products on ANDA 203846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2015	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
04/18/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/18/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/18/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/18/2024	SUPPL-2	Labeling		Label is not available on this site.
04/18/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203846

METHAMPHETAMINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AA	005378	AJENAT PHARMS
METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	091189	DR REDDYS LABS SA
METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	203846	HIKMA