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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210527
Company: ALEMBIC PHARMS LTD
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
06/13/2018 ORIG-1 Approval STANDARD

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 207774 CADILA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 062500 CHARTWELL
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

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 207774 CADILA
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
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
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 050007 PFIZER
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