Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078949
Company: APOTEX INC

Products on ANDA 078949

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUDESONIDE	BUDESONIDE	0.032MG/INH	SPRAY, METERED;NASAL	Prescription	None	No	No
BUDESONIDE	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078949

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/12/2014	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
10/29/2019	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/20/2015	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

BUDESONIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.032MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
BUDESONIDE	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	078949	APOTEX INC
RHINOCORT ALLERGY	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	020746	J AND J CONSUMER INC