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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040189

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METHYLPREDNISOLONE (METHYLPREDNISOLONE)
4MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: METHYLPREDNISOLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040189
Product Number: 001
Approval Date: Oct 31, 1997
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE (METHYLPREDNISOLONE)
8MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: METHYLPREDNISOLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040189
Product Number: 002
Approval Date: Oct 31, 1997
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE (METHYLPREDNISOLONE)
16MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: METHYLPREDNISOLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040189
Product Number: 003
Approval Date: Jul 20, 2007
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE (METHYLPREDNISOLONE)
32MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: METHYLPREDNISOLONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040189
Product Number: 004
Approval Date: Jul 20, 2007
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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