Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062337
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Discontinued None No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;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
03/29/1982 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
06/30/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

09/02/2014 SUPPL-24 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/23/2002 SUPPL-23 Labeling

Label is not available on this site.

02/05/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/01/1993 SUPPL-17 Labeling

Label is not available on this site.

12/16/1992 SUPPL-16 Labeling

Label is not available on this site.

05/12/1992 SUPPL-15 Labeling

Label is not available on this site.

05/12/1992 SUPPL-14 Labeling

Label is not available on this site.

01/31/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/25/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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