Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090134
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;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
12/14/2011 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
03/27/2018 SUPPL-18 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090134Orig1s018ltr.pdf
12/27/2017 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

12/27/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/27/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/22/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

DOXYCYCLINE HYCLATE

TABLET, DELAYED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE PHARMS INC

TABLET, DELAYED RELEASE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE PHARMS INC

TABLET, DELAYED RELEASE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090431 MYLAN

TABLET, DELAYED RELEASE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE PHARMS INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 207494 PRINSTON INC

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