Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204380
Company: ACTAVIS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription AB No No
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription AB 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
03/23/2017 ORIG-1 Approval

Label is not available on this site.

DAPSONE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 204380 ACTAVIS LLC
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 205429 ALVOGEN
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 086841 JACOBUS
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 203887 NOSTRUM LABS INC
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 206505 NOVITIUM PHARMA
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 209430 TARO PHARM
DAPSONE DAPSONE 25MG TABLET;ORAL Prescription No AB 204074 VIRTUS PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 204380 ACTAVIS LLC
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 205429 ALVOGEN
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 086842 JACOBUS
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 203887 NOSTRUM LABS INC
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 206505 NOVITIUM PHARMA
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 209430 TARO PHARM
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription No AB 204074 VIRTUS PHARMS

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