Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213342

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HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE)
100MG
Marketing Status: Prescription

Active Ingredient: HYDROXYCHLOROQUINE SULFATE
Proprietary Name: HYDROXYCHLOROQUINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213342
Product Number: 002
Approval Date: Aug 18, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE)
200MG
Marketing Status: Prescription

Active Ingredient: HYDROXYCHLOROQUINE SULFATE
Proprietary Name: HYDROXYCHLOROQUINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213342
Product Number: 001
Approval Date: Apr 7, 2020
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE)
300MG
Marketing Status: Prescription

Active Ingredient: HYDROXYCHLOROQUINE SULFATE
Proprietary Name: HYDROXYCHLOROQUINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213342
Product Number: 003
Approval Date: Aug 18, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE)
400MG
Marketing Status: Prescription

Active Ingredient: HYDROXYCHLOROQUINE SULFATE
Proprietary Name: HYDROXYCHLOROQUINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A213342
Product Number: 004
Approval Date: Aug 18, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information