Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076266
Company: CHARTWELL INJECTABLE

Products on ANDA 076266

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXAPRAM HYDROCHLORIDE	DOXAPRAM HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076266

DOXAPRAM HYDROCHLORIDE

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOPRAM	DOXAPRAM HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	014879	HIKMA
DOXAPRAM HYDROCHLORIDE	DOXAPRAM HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076266	CHARTWELL INJECTABLE