Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062421
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;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
02/02/1983 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
01/02/2018 SUPPL-68 Labeling-Package Insert

Label is not available on this site.

01/02/2018 SUPPL-67 Labeling-Package Insert

Label is not available on this site.

01/02/2018 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

12/14/2012 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

07/28/2010 SUPPL-52 Labeling

Label is not available on this site.

09/01/2005 SUPPL-32 Labeling

Label is not available on this site.

12/23/2002 SUPPL-28 Labeling

Label is not available on this site.

04/18/2003 SUPPL-27 Labeling

Label is not available on this site.

04/25/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2001 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

12/26/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2000 SUPPL-23 Labeling

Label is not available on this site.

09/01/1993 SUPPL-21 Labeling

Label is not available on this site.

04/14/1993 SUPPL-20 Labeling

Label is not available on this site.

10/23/1992 SUPPL-19 Labeling

Label is not available on this site.

02/26/1992 SUPPL-18 Labeling

Label is not available on this site.

11/15/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/01/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

DOXYCYCLINE HYCLATE

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062421 ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 207773 CADILA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062269 CARIBE HOLDINGS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 211343 CHANGZHOU PHARM
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062505 CHARTWELL LIFE SCI
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 209969 EMCURE PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 065095 HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062432 MYLAN
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 207558 NOVEL LABS INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062677 SUN PHARM INDUSTRIES

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