Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076103
Company: BAUSCH

Products on ANDA 076103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076103

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/2003/076103_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-7	Labeling-Package Insert		Label is not available on this site.
03/12/2008	SUPPL-5	Labeling		Label is not available on this site.
01/27/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076103

IPRATROPIUM BROMIDE

SPRAY, METERED;NASAL; 0.042MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	215105	AMNEAL
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076155	APOTEX INC
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076103	BAUSCH
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076598	HIKMA