Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211745
Company: MICRO LABS
Company: MICRO LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 02/27/2020 | ORIG-1 | Approval | STANDARD |
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 |
|---|---|---|---|---|---|---|---|---|
| RANEXA | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021526 | GILEAD |
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212930 | ACCORD HLTHCARE |
| 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 | 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 | 212889 | GRAVITI 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 | 212781 | PRAXGEN |
| 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 |
TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RANEXA | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021526 | GILEAD |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212930 | ACCORD HLTHCARE |
| 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 | 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 | 212889 | GRAVITI 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 | 212781 | PRAXGEN |
| 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 |
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