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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217912
Company: LUPIN

Products on ANDA 217912

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 217912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217912

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
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	217912	LUPIN
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	219222	RUBICON RESEARCH

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