Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210252
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
05/24/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210252Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/15/2024 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
FINGOLIMOD HYDROCHLORIDE
CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207991 | ACCORD HLTHCARE |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208004 | ALKEM LABS LTD |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207993 | APOTEX |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207983 | AUROBINDO PHARMA LTD |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207979 | BIOCON LTD |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210252 | BIONPHARMA |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208000 | DR REDDYS |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207945 | EZRA VENTURES |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207985 | GLENMARK PHARMS LTD |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207939 | HEC PHARM CO LTD |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207933 | HETERO LABS LTD V |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208005 | MYLAN |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208003 | PRINSTON INC |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208014 | SUN PHARM |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208008 | TEVA PHARMS USA |
FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207994 | ZYDUS PHARMS |
GILENYA | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022527 | NOVARTIS |