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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086842
Company: JACOBUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPSONE DAPSONE 100MG TABLET;ORAL Prescription AB Yes 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
07/03/1979 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
08/24/2009 SUPPL-18 Labeling

Label is not available on this site.

08/19/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/13/1988 SUPPL-12 Labeling

Label is not available on this site.

07/13/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/02/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/04/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/04/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DAPSONE

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 Yes 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 207165 RISING
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