Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091168
Company: CIPLA

Products on ANDA 091168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2018	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091168s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/091168Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/22/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091168

EMTRICITABINE

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	No	AB	079188	AUROBINDO PHARMA LTD
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	No	AB	091168	CIPLA
EMTRIVA	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	Yes	AB	021500	GILEAD