Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201678
Company: LUPIN LTD

Products on ANDA 201678

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE	DOXYCYCLINE	EQ 25MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201678

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-17	Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/26/2025	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/26/2025	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/26/2025	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/26/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/26/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/06/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/25/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201678

DOXYCYCLINE

FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 25MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065454	CHARTWELL
DOXYCYCLINE	DOXYCYCLINE	EQ 25MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	201678	LUPIN LTD