Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050138
Company: KING PHARMS LLC
Company: KING PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BICILLIN C-R | PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| BICILLIN C-R | PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| BICILLIN C-R 900/300 | PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/25/2026 | SUPPL-247 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/50-138s247lbl.pdf | |
| 06/25/2026 | SUPPL-246 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050138s246lbl.pdf | |
| 12/10/2020 | SUPPL-242 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050138s242lbl.pdf | |
| 12/08/2020 | SUPPL-243 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050138s243lbl.pdf | |
| 08/26/2019 | SUPPL-241 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050138s241lbl.pdf | |
| 04/30/2019 | SUPPL-240 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050138s240,050141s237lbl.pdf | |
| 11/05/2018 | SUPPL-239 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050138s039lbl.pdf | |
| 10/13/2015 | SUPPL-236 | 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/2015/050138s236lbl.pdf |
| 04/25/2014 | SUPPL-235 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf | |
| 09/06/2012 | SUPPL-234 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050138s234lbl.pdf | |
| 12/18/2009 | SUPPL-231 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050138s231lbl.pdf |