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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215104
Company: AMNEAL
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/16/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

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
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