Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211139
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription AA No No
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG 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
09/26/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211139Orig1s000ltr.pdf

AMPHETAMINE SULFATE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 211139 AMNEAL PHARMS
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 211639 AUROLIFE PHARMA LLC
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 212619 GRANULES PHARMS
EVEKEO AMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 200166 ARBOR PHARMS LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 211139 AMNEAL PHARMS
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 211639 AUROLIFE PHARMA LLC
AMPHETAMINE SULFATE AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 212619 GRANULES PHARMS
EVEKEO AMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 200166 ARBOR PHARMS LLC

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