Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206465
Company: ALKEM LABS LTD
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
03/21/2017 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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