Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016758
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAVANE | THIOTHIXENE HYDROCHLORIDE | EQ 5MG BASE/ML | CONCENTRATE;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/06/1970 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/2009 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf | |
04/07/2008 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf | |
05/19/2003 | SUPPL-17 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf | |
07/31/2001 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf |
07/31/2001 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf |
12/10/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/01/1975 | SUPPL-4 | 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 |
---|---|---|---|---|---|
07/19/2009 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf | |
04/07/2008 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf | |
05/19/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf |