Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062269
Company: CARIBE HOLDINGS
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
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET;ORAL Prescription 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
11/08/1982 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
10/27/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

07/14/2016 SUPPL-27 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

05/19/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

11/22/2013 SUPPL-21 Labeling-Container/Carton Labels

Label is not available on this site.

04/18/2003 SUPPL-20 Labeling

Label is not available on this site.

04/18/2003 SUPPL-18 Labeling

Label is not available on this site.

09/26/2002 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/28/2002 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

07/24/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

12/06/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

11/12/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/07/1994 SUPPL-5 Labeling

Label is not available on this site.

08/31/1993 SUPPL-4 Labeling

Label is not available on this site.

08/31/1993 SUPPL-3 Labeling

Label is not available on this site.

07/29/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/05/1992 SUPPL-1 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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