Product Details for NDA 009986
DELTASONE (PREDNISONE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PREDNISONE
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
DELTASONE (PREDNISONE)
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PREDNISONE
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
DELTASONE (PREDNISONE)
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PREDNISONE
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
DELTASONE (PREDNISONE)
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PREDNISONE
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
DELTASONE (PREDNISONE)
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PREDNISONE
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DELTASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N009986
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status: Discontinued
Patent and Exclusivity Information