Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090473
Company: CHARTWELL

Products on ANDA 090473

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	None	No	No
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2010	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090473Orig1s000LBL.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/29/2010	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090473

BENZPHETAMINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090473	CHARTWELL
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090346	EPIC PHARMA LLC
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090968	KVK TECH