Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091052
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG 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
02/08/2012 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091052Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/02/2016 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

12/02/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/02/2016 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

11/04/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/25/2012 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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