Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201452
Company: ARROW INTL
Company: ARROW INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/2023 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 05/21/2021 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201452Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/05/2021 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
LENALIDOMIDE
CAPSULE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 214618 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |