Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAVANE | THIOTHIXENE HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
NAVANE | THIOTHIXENE HYDROCHLORIDE | EQ 10MG BASE/VIAL | 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 |
---|---|---|---|---|---|---|---|
08/19/1971 | 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-34 | 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-33 | 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 | |
08/02/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/25/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/15/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/19/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/10/1987 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/26/1985 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/17/1984 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/08/1983 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/10/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/18/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
01/18/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/10/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
06/02/1981 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/21/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/12/1979 | SUPPL-8 | Manufacturing (CMC)-Formulation |
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-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf | |
04/07/2008 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf |
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