Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202584
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/30/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202584Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |