Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021855
Company: BIONPHARMA
Company: BIONPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE;ORAL | Over-the-counter | None | Yes | No |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Over-the-counter | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021855lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021855ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021855s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/22/2020 | SUPPL-14 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021855Orig1s014ltr.pdf |
| 01/31/2019 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021855Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021855Orig1s009ltr.pdf | |
| 03/09/2017 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021855Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021855Orig1s006ltr.pdf | |
| 12/11/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/31/2019 | SUPPL-9 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021855Orig1s009lbl.pdf | |
| 03/09/2017 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021855Orig1s006lbl.pdf | |
| 08/04/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021855lbl.pdf |
LOPERAMIDE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 2MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Over-the-counter | Yes | 021855 | BIONPHARMA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Over-the-counter | No | 213070 | STRIDES PHARMA |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 1MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE;ORAL | Over-the-counter | Yes | 021855 | BIONPHARMA |