Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076103
Company: BAUSCH
Company: BAUSCH
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 |
---|---|---|---|---|---|---|---|
03/31/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076103_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/06/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/12/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
01/27/2005 | SUPPL-1 | 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 |