Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065454
Company: CHARTWELL LIFE SCI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;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
07/16/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065454s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf

DOXYCYCLINE

FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065454 CHARTWELL LIFE SCI
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 201678 LUPIN LTD
VIBRAMYCIN DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050006 PFIZER

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