Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212160
Company: WINDER LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 2.5MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 7.5MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 20MG TABLET;ORAL Prescription AA No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 30MG 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
06/07/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

DEXTROAMPHETAMINE SULFATE

TABLET;ORAL; 2.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 2.5MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 2.5MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 202893 AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 203548 AVANTHI INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 040361 BARR
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 206588 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 204330 NOVEL LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 210059 NUVO PHARM
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 040436 SPECGX LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

TABLET;ORAL; 7.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 7.5MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 7.5MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 202893 AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 203548 AVANTHI INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 040361 BARR
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 206588 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 204330 NOVEL LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 210059 NUVO PHARM
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 040436 SPECGX LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

TABLET;ORAL; 15MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

TABLET;ORAL; 20MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 20MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 20MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

TABLET;ORAL; 30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 30MG TABLET;ORAL Prescription No AA 090533 ARBOR PHARMS LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 30MG TABLET;ORAL Prescription No AA 212160 WINDER LABS LLC

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