Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076598
Company: HIKMA
Company: HIKMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/05/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076598_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/12/2011 | SUPPL-8 | Labeling-Package Insert |
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 |