Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091189
Company: MAYNE PHARMA INC
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
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
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.

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 RECORDATI RARE
METHAMPHETAMINE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 203846 HIKMA
METHAMPHETAMINE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 091189 MAYNE PHARMA INC

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