Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040776
Company: OUTLOOK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/29/2008 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/040776Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/27/2016 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-2 Labeling-Patient Package Insert

Label is not available on this site.

DEXTROAMPHETAMINE SULFATE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION;ORAL Prescription No AA 040776 OUTLOOK PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG/5ML SOLUTION;ORAL Prescription No AA 203644 TRIS PHARMA INC

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