Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065454
Company: CHARTWELL

Products on ANDA 065454

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065454

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2008	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065454s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/21/2021	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/21/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/21/2021	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 065454

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065454s000lbl.pdf

Therapeutic Equivalents for ANDA 065454

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