Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212059
Company: ZHEJIANG YONGTAI
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
11/04/2019 ORIG-1 Approval STANDARD

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 PHARMS
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 079171 SANDOZ 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 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 PHARMS
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 079171 SANDOZ 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 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 PHARMS
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 079171 SANDOZ 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 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 PHARMS
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 079171 SANDOZ 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 079167 WATSON LABS INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 212059 ZHEJIANG YONGTAI

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