Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090431
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 80MG BASE TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Discontinued None 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
12/28/2010 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
05/23/2016 SUPPL-10 Manufacturing (CMC)-New Strength Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/90431Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s010ltr.pdf
12/11/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/16/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/16/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/29/2016 SUPPL-5 Manufacturing (CMC)-New Strength Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090431Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s005ltr.pdf
05/19/2016 SUPPL-4 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s004ltr.pdf
12/15/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/23/2016 SUPPL-10 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/90431Orig1s010lbl.pdf
04/29/2016 SUPPL-5 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090431Orig1s005lbl.pdf

DOXYCYCLINE HYCLATE

TABLET, DELAYED RELEASE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090431 MYLAN

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