Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200065
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;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
02/17/2011 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/14/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

DOXYCYCLINE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 200065 IMPAX LABS INC
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 202778 MYLAN PHARMS INC
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065055 PAR PHARM

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