Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062505
Company: CHARTWELL LIFE SCI
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
09/11/1984 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
12/02/2014 SUPPL-70 Labeling-Package Insert

Label is not available on this site.

04/25/2012 SUPPL-68 Labeling-Package Insert

Label is not available on this site.

06/30/2008 SUPPL-59 Labeling

Label is not available on this site.

03/28/2006 SUPPL-56 Labeling

Label is not available on this site.

04/26/2005 SUPPL-39 Labeling

Label is not available on this site.

07/27/2004 SUPPL-37 Labeling

Label is not available on this site.

12/09/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2002 SUPPL-33 Labeling

Label is not available on this site.

12/21/2001 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/20/2002 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2002 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2002 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/2000 SUPPL-26 Labeling

Label is not available on this site.

07/26/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/08/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/08/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/08/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/08/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/08/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/04/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/22/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/27/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/13/1994 SUPPL-12 Labeling

Label is not available on this site.

06/09/1993 SUPPL-11 Labeling

Label is not available on this site.

11/06/1992 SUPPL-10 Labeling

Label is not available on this site.

09/03/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/01/1992 SUPPL-7 Labeling

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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