Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079169
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079169Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/13/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/13/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/13/2023 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/07/2020 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/07/2020 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ROSUVASTATIN CALCIUM
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK SPECLT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK SPECLT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK SPECLT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CRESTOR | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021366 | IPR |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206434 | ACCORD HLTHCARE |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206465 | ALKEM LABS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079170 | AUROBINDO PHARMA LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207752 | BIOCON PHARMA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207453 | CADILA PHARMS LTD |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207408 | CHANGZHOU PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079168 | CHARTWELL RX |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079172 | GLENMARK SPECLT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207616 | HETERO LABS LTD V |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205587 | LUPIN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 208898 | MSN |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207062 | RENATA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206381 | SCIEGEN PHARMS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207375 | SHANDONG |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079169 | SUN PHARM |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 201619 | TORRENT |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207626 | UMEDICA |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 079167 | WATSON LABS INC |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 212059 | ZHEJIANG YONGTAI |