Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075111
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
04/22/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium%20Bromide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75111ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/21/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/25/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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04/03/2001 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/17/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
08/17/2000 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/17/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/23/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/23/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/23/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/22/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium%20Bromide_prntlbl.pdf |