Product Details for NDA 022021
ALTACE (RAMIPRIL)
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: RAMIPRIL
Proprietary Name: ALTACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022021
Product Number: 001
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ALTACE (RAMIPRIL)
Proprietary Name: ALTACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022021
Product Number: 001
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: RAMIPRIL
Proprietary Name: ALTACE
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Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022021
Product Number: 002
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ALTACE (RAMIPRIL)
Proprietary Name: ALTACE
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: N022021
Product Number: 002
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
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: RAMIPRIL
Proprietary Name: ALTACE
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: N022021
Product Number: 003
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ALTACE (RAMIPRIL)
Proprietary Name: ALTACE
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: N022021
Product Number: 003
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
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: RAMIPRIL
Proprietary Name: ALTACE
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: N022021
Product Number: 004
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ALTACE
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: N022021
Product Number: 004
Approval Date: Feb 27, 2007
Applicant Holder Full Name: KING PHARMACEUTICALS INC SUB PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information