Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016194
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

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