Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 206434
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ROSUVASTATIN CALCIUM
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079168 | ALLIED |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079145 | APOTEX INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207062 | JUBILANT GENERICS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 208898 | MSN LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079171 | SANDOZ INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 206513 | ZYDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079168 | ALLIED |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079145 | APOTEX INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207062 | JUBILANT GENERICS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 208898 | MSN LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079171 | SANDOZ INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 206513 | ZYDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079168 | ALLIED |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079145 | APOTEX INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207062 | JUBILANT GENERICS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 208898 | MSN LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079171 | SANDOZ INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 206513 | ZYDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079168 | ALLIED |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079145 | APOTEX INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK PHARMS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207062 | JUBILANT GENERICS |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 208898 | MSN LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079171 | SANDOZ INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA LABS PVT LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 206513 | ZYDUS PHARMS |
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