Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213614
Company: MANKIND PHARMA
Company: MANKIND PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/09/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/08/2023 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213614s017ltr.pdf |
| 05/05/2022 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/18/2021 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/26/2022 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
ALOSETRON HYDROCHLORIDE
TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206647 | AMNEAL PHARMS |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 213614 | MANKIND PHARMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 209180 | RISING |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021107 | SEBELA IRELAND LTD |
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 206647 | AMNEAL PHARMS |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 213614 | MANKIND PHARMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 209180 | RISING |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021107 | SEBELA IRELAND LTD |