Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022021

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ALTACE (RAMIPRIL)
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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 efficacy 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

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