Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208324
Company: ALEMBIC

Products on ANDA 208324

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208324

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208324Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 208324

VARDENAFIL HYDROCHLORIDE

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	208324	ALEMBIC
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	205988	MACLEODS PHARMS LTD