Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROBICIN | SPECTINOMYCIN HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
TROBICIN | SPECTINOMYCIN HYDROCHLORIDE | EQ 4GM 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 |
---|---|---|---|---|---|---|---|
06/30/1971 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/15/2012 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050347s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050347Orig1s060ltr.pdf |
11/15/2011 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050347s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050347s058ltr.pdf | |
08/19/2004 | SUPPL-52 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50347s052ltr.pdf |
05/15/2002 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/21/2001 | SUPPL-48 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
07/17/2001 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/01/1996 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/1996 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1995 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
10/30/1981 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/08/1980 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
09/10/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/09/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
04/10/1979 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/10/1979 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
07/13/1978 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/1977 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/04/1976 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1976 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
09/12/1975 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
06/03/1975 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
07/08/1975 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
12/24/1974 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
05/23/1974 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
06/18/1973 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
03/09/1973 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
12/05/1972 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
10/24/1972 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
08/21/1972 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
04/10/1972 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
02/25/1972 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
10/04/1971 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
09/10/1971 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
08/19/1971 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
07/06/1971 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
08/26/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/23/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/22/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/15/2012 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050347s060lbl.pdf |
11/15/2011 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050347s058lbl.pdf |