Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210188
Company: CADILA
Company: CADILA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/19/2019 | 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 |
|---|---|---|---|---|---|
| 01/22/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
RANOLAZINE
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208862 | ACTAVIS ELIZABETH |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210054 | AJANTA PHARMA LTD |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209953 | ALKEM LABS LTD |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209081 | AUROBINDO PHARMA |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210188 | CADILA |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211082 | GLENMARK PHARMS LTD |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212788 | HETERO LABS LTD III |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213517 | I3 PHARMS |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201046 | LUPIN LTD |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212284 | MANKIND PHARMA |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211745 | MICRO LABS |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210668 | NOVAST LABS LTD |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213085 | PIRAMAL HLTHCARE UK |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212781 | PRAXGEN |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212889 | RISING |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211829 | SCIEGEN PHARMS INC |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211707 | SUN PHARM |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211865 | SUNSHINE |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214035 | VKT PHARMA |
TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208862 | ACTAVIS ELIZABETH |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210054 | AJANTA PHARMA LTD |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209953 | ALKEM LABS LTD |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209081 | AUROBINDO PHARMA |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210188 | CADILA |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211082 | GLENMARK PHARMS LTD |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212788 | HETERO LABS LTD III |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213517 | I3 PHARMS |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201046 | LUPIN LTD |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212284 | MANKIND PHARMA |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211745 | MICRO LABS |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213085 | PIRAMAL HLTHCARE UK |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212781 | PRAXGEN |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212889 | RISING |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211829 | SCIEGEN PHARMS INC |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211707 | SUN PHARM |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211865 | SUNSHINE |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214035 | VKT PHARMA |