Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091189
Company: DR REDDYS LABS SA

Products on ANDA 091189

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 091189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2010	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
02/07/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/14/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/02/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/02/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/02/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091189

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