Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050141
Company: KING PHARMS LLC
Company: KING PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BICILLIN L-A | PENICILLIN G BENZATHINE | 600,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | BC | Yes | Yes |
| BICILLIN L-A | PENICILLIN G BENZATHINE | 300,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/25/2026 | SUPPL-243 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050141s243lbl.pdf | |
| 06/25/2026 | SUPPL-242 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050141s242lbl.pdf | |
| 01/25/2021 | SUPPL-240 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050141Orig1s240lbl.pdf | |
| 12/10/2020 | SUPPL-238 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050141s238lbl.pdf | |
| 12/08/2020 | SUPPL-239 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050141s239lbl.pdf | |
| 04/30/2019 | SUPPL-237 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050141s237lbl.pdf | |
| 11/07/2018 | SUPPL-236 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050141s236lbl.pdf | |
| 10/13/2015 | SUPPL-233 | 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/2015/050141s233lbl.pdf |
| 04/25/2014 | SUPPL-232 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050138s235,050141s232lbl.pdf | |
| 09/06/2012 | SUPPL-231 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050141s231lbl.pdf | |
| 12/18/2009 | SUPPL-226 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050141s226lbl.pdf |