Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062676
Company: SUN PHARM INDUSTRIES
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
07/10/1986 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
05/15/2018 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

05/15/2018 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

05/15/2018 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

05/15/2018 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

09/10/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

07/24/2013 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

11/30/2011 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

05/29/2008 SUPPL-33 Labeling

Label is not available on this site.

09/28/2006 SUPPL-31 Labeling

Label is not available on this site.

03/08/2006 SUPPL-27 Labeling

Label is not available on this site.

07/06/2005 SUPPL-23 Labeling

Label is not available on this site.

04/01/2003 SUPPL-20 Labeling

Label is not available on this site.

02/26/2002 SUPPL-16 Labeling

Label is not available on this site.

04/12/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

07/20/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/20/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/21/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/06/1993 SUPPL-6 Labeling

Label is not available on this site.

03/26/1993 SUPPL-5 Labeling

Label is not available on this site.

01/12/1993 SUPPL-4 Labeling

Label is not available on this site.

03/16/1992 SUPPL-3 Labeling

Label is not available on this site.

05/01/1989 SUPPL-1 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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