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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213075
Company: ALEMBIC

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 150MG 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
01/03/2022 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2026 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
03/26/2026 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

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
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 213075 ALEMBIC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE

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
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 213075 ALEMBIC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE

TABLET, DELAYED RELEASE;ORAL; EQ 150MG 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 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 213075 ALEMBIC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 207494 PRINSTON INC

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
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 213075 ALEMBIC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 207494 PRINSTON INC
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