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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214216
Company: MACLEODS PHARMS LTD

Products on ANDA 214216

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214216Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 214216

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL; 200MG;EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESCOVY	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	208215	GILEAD SCIENCES INC
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	213926	LUPIN LTD
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	214216	MACLEODS PHARMS LTD

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