Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075562
Company: NEPHRON

Products on ANDA 075562

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075562

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75562.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075562.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075562

IPRATROPIUM BROMIDE

SOLUTION;INHALATION; 0.02%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	206543	LUOXIN AUROVITAS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	075562	NEPHRON
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	075693	RITEDOSE CORP
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Prescription	No	AN	207903	SUN PHARM