Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062031
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 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
10/13/1982 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
01/02/2018 SUPPL-80 Labeling-Package Insert

Label is not available on this site.

01/02/2018 SUPPL-79 Labeling-Package Insert

Label is not available on this site.

04/30/2014 SUPPL-74 Labeling-Package Insert

Label is not available on this site.

07/28/2010 SUPPL-63 Labeling

Label is not available on this site.

09/01/2005 SUPPL-43 Labeling

Label is not available on this site.

12/23/2002 SUPPL-39 Labeling

Label is not available on this site.

02/20/2002 SUPPL-38 Labeling

Label is not available on this site.

04/25/2001 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2000 SUPPL-35 Labeling

Label is not available on this site.

06/16/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/23/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/10/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/10/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/10/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/01/1993 SUPPL-28 Labeling

Label is not available on this site.

04/14/1993 SUPPL-27 Labeling

Label is not available on this site.

10/23/1992 SUPPL-26 Labeling

Label is not available on this site.

02/26/1992 SUPPL-25 Labeling

Label is not available on this site.

11/15/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/15/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/16/1988 SUPPL-16 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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