Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075170
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75170ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75170_Butorphanol%20Tartrate.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 05/03/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/2001 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/13/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 12/01/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 08/18/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 07/22/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |