Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TALWIN | PENTAZOCINE LACTATE | EQ 30MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/1967 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016194s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016194Orig1s081ltr.pdf | |
| 12/16/2016 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016194Orig1s079,s080ltr.pdf | |
| 12/16/2016 | SUPPL-79 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016194Orig1s079,s080ltr.pdf | |
| 05/27/2004 | SUPPL-68 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16194scs068ltr.pdf |
| 09/26/2001 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/2001 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 10/22/1998 | SUPPL-61 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 10/10/1995 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/1990 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1989 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 09/22/1989 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1988 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1988 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 07/15/1985 | SUPPL-49 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/24/1983 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/01/1983 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/18/1983 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 03/18/1981 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1981 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 08/07/1981 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/05/1980 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1981 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 07/18/1978 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 07/21/1978 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 01/04/1977 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/16/1977 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1977 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1978 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 12/15/1977 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1976 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1976 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/26/1976 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1975 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/25/1974 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/06/1974 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/26/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016194s081lbl.pdf | |
| 12/16/2016 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf | |
| 12/16/2016 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf | |
| 12/16/2016 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016194s079s080lbl.pdf |