Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210536
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Discontinued None No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET;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
05/14/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

DOXYCYCLINE HYCLATE

TABLET;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 TABLET;ORAL Prescription No AB 210536 ALEMBIC PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET;ORAL Prescription No AB 062269 CARIBE HOLDINGS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET;ORAL Prescription No AB 062505 CHARTWELL

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