Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072741
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/02/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 218122 | AUROBINDO PHARMA LTD |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 215579 | BIONPHARMA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 215001 | EDENBRIDGE PHARMS |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 217840 | JUBILANT CADISTA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 072741 | MYLAN |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 216876 | RUBICON |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 073192 | TEVA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 217471 | ZYDUS LIFESCIENCES |