Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076025
Company: BAUSCH

Products on ANDA 076025

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076025

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076025_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/20/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076025

IPRATROPIUM BROMIDE

SPRAY, METERED;NASAL; 0.021MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	215104	AMNEAL
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076156	APOTEX INC
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076025	BAUSCH
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076664	HIKMA