Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062396
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;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
11/07/1984 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
10/30/2018 SUPPL-67 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-53 Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-52 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/21/2015 SUPPL-51 Labeling-Container/Carton Labels

Label is not available on this site.

09/21/2015 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

11/30/2011 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

11/18/2010 SUPPL-42 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/15/2010 SUPPL-40 Labeling

Label is not available on this site.

06/30/2008 SUPPL-39 Labeling

Label is not available on this site.

05/31/2007 SUPPL-38 Labeling

Label is not available on this site.

05/08/2006 SUPPL-37 Labeling

Label is not available on this site.

10/04/2004 SUPPL-35 Labeling

Label is not available on this site.

10/24/2003 SUPPL-34 Labeling

Label is not available on this site.

12/09/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/2002 SUPPL-32 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/22/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/2001 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/2000 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/16/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/08/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/11/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/17/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/16/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/14/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/02/1993 SUPPL-18 Labeling

Label is not available on this site.

06/08/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/12/1993 SUPPL-16 Labeling

Label is not available on this site.

12/05/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/05/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

DOXYCYCLINE HYCLATE

CAPSULE;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 CAPSULE;ORAL Prescription No AB 062031 ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 210527 ALEMBIC PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 207289 AMNEAL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209402 CHANGZHOU PHARM
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062500 CHARTWELL LIFE SCI
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062396 HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062676 SUN PHARM INDUSTRIES
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 207774 ZYDUS PHARMS
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 050007 PFIZER

CAPSULE;ORAL; EQ 50MG 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 50MG BASE CAPSULE;ORAL Prescription No AB 062031 ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 210527 ALEMBIC PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 062500 CHARTWELL LIFE SCI
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 062396 HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 062676 SUN PHARM INDUSTRIES
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 207774 ZYDUS PHARMS

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