Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062500
Company: CHARTWELL LIFE SCI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG 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
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-45 Labeling-Package Insert

Label is not available on this site.

06/30/2008 SUPPL-42 Labeling

Label is not available on this site.

03/28/2006 SUPPL-38 Labeling

Label is not available on this site.

04/26/2005 SUPPL-30 Labeling

Label is not available on this site.

07/27/2004 SUPPL-29 Labeling

Label is not available on this site.

04/11/2002 SUPPL-25 Labeling

Label is not available on this site.

03/12/2002 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

07/26/2000 SUPPL-22 Labeling

Label is not available on this site.

07/26/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/18/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/18/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/13/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/1994 SUPPL-8 Labeling

Label is not available on this site.

06/09/1993 SUPPL-7 Labeling

Label is not available on this site.

06/22/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/03/1992 SUPPL-5 Labeling

Label is not available on this site.

06/19/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/19/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/19/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/22/1991 SUPPL-1 Labeling

Label is not available on this site.

DOXYCYCLINE HYCLATE

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

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

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