Product Details for NDA 019152
CALAN SR (VERAPAMIL HYDROCHLORIDE)
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: CALAN SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019152
Product Number: 003
Approval Date: Mar 6, 1991
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CALAN SR (VERAPAMIL HYDROCHLORIDE)
Proprietary Name: CALAN SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019152
Product Number: 003
Approval Date: Mar 6, 1991
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: CALAN SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019152
Product Number: 002
Approval Date: Dec 15, 1989
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CALAN SR (VERAPAMIL HYDROCHLORIDE)
Proprietary Name: CALAN SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 180MG **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: N019152
Product Number: 002
Approval Date: Dec 15, 1989
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: CALAN SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 240MG **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: N019152
Product Number: 001
Approval Date: Dec 16, 1986
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CALAN SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 240MG **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: N019152
Product Number: 001
Approval Date: Dec 16, 1986
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information