Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050429
Company: TP ANDA HOLDINGS
Company: TP ANDA HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIMACTANE | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/12/2026 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050429s088lbl.pdf | |
| 08/16/2023 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050429s087lbl.pdf | |
| 01/23/2019 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050429s086lbl.pdf | |
| 11/18/2004 | SUPPL-83 | Labeling | 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/2004/50429s083lbl.pdf |