Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076155
Company: APOTEX INC
Company: APOTEX INC
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 | 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 |
---|---|---|---|---|---|---|---|
04/18/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/18/2015 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
03/24/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
05/22/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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 |