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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011153

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MEDROL (METHYLPREDNISOLONE)
2MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: MEDROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011153
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MEDROL (METHYLPREDNISOLONE)
4MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: MEDROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011153
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MEDROL (METHYLPREDNISOLONE)
8MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: MEDROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011153
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MEDROL (METHYLPREDNISOLONE)
16MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: MEDROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011153
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MEDROL (METHYLPREDNISOLONE)
32MG
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: MEDROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 32MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N011153
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MEDROL (METHYLPREDNISOLONE)
24MG
Marketing Status: Discontinued
Active Ingredient: METHYLPREDNISOLONE
Proprietary Name: MEDROL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 24MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011153
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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