Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050347
Company: PFIZER
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 |
| 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 |