Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215104
Company: AMNEAL
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 |