Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062497
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXY-LEMMON DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Discontinued None No No
DOXY-LEMMON 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
08/23/1984 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
05/19/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

08/30/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

01/26/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/23/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/23/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/23/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/26/1992 SUPPL-14 Labeling

Label is not available on this site.

10/03/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/03/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/09/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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