Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202496
Company: RITEDOSE CORP

Products on ANDA 202496

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202496

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2012	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202496

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

SOLUTION;INHALATION; EQ 0.083% BASE;0.017%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION	Prescription	No	AN	077559	CIPLA
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION	Prescription	No	AN	076749	NEPHRON
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION	Prescription	No	AN	202496	RITEDOSE CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION	Prescription	No	AN	207875	SUN PHARM