Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076598
Company: HIKMA

Products on ANDA 076598

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076598

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076598_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076598

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