Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050347
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English