Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079167
Company: WATSON LABS INC
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
04/29/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079167Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079167Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2016 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/29/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079167Orig1s000lbl.pdf

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 208850 AMNEAL PHARMS CO
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 079161 MYLAN PHARMS INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 5MG TABLET;ORAL Prescription No AB 079171 SANDOZ INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 5MG TABLET;ORAL Prescription No AB 079169 SUN PHARMA GLOBAL
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 5MG TABLET;ORAL Prescription No AB 079166 TEVA PHARMS USA
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 5MG TABLET;ORAL Prescription No AB 201619 TORRENT PHARMS LTD
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 5MG TABLET;ORAL Prescription No AB 079167 WATSON LABS INC

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 208850 AMNEAL PHARMS CO
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 079161 MYLAN PHARMS INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 10MG TABLET;ORAL Prescription No AB 079171 SANDOZ INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 10MG TABLET;ORAL Prescription No AB 079169 SUN PHARMA GLOBAL
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 10MG TABLET;ORAL Prescription No AB 079166 TEVA PHARMS USA
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 10MG TABLET;ORAL Prescription No AB 201619 TORRENT PHARMS LTD
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 10MG TABLET;ORAL Prescription No AB 079167 WATSON LABS INC

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 208850 AMNEAL PHARMS CO
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 079161 MYLAN PHARMS INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 20MG TABLET;ORAL Prescription No AB 079171 SANDOZ INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 20MG TABLET;ORAL Prescription No AB 079169 SUN PHARMA GLOBAL
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 20MG TABLET;ORAL Prescription No AB 079166 TEVA PHARMS USA
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 20MG TABLET;ORAL Prescription No AB 201619 TORRENT PHARMS LTD
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 20MG TABLET;ORAL Prescription No AB 079167 WATSON LABS INC

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 208850 AMNEAL PHARMS CO
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 079161 MYLAN PHARMS INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 40MG TABLET;ORAL Prescription No AB 079171 SANDOZ INC
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 40MG TABLET;ORAL Prescription No AB 079169 SUN PHARMA GLOBAL
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 40MG TABLET;ORAL Prescription No AB 079166 TEVA PHARMS USA
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 40MG TABLET;ORAL Prescription No AB 201619 TORRENT PHARMS LTD
ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM 40MG TABLET;ORAL Prescription No AB 079167 WATSON LABS INC

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