Product Details for ANDA 207626
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
EQ 5MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Prescription
EQ 20MG BASE
Marketing Status: Prescription
EQ 40MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 001
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 001
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 002
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 002
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 003
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 003
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 004
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207626
Product Number: 004
Approval Date: Apr 9, 2019
Applicant Holder Full Name: UMEDICA LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information