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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018830

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TAMBOCOR (FLECAINIDE ACETATE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLECAINIDE ACETATE
Proprietary Name: TAMBOCOR
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Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018830
Product Number: 004
Approval Date: Aug 23, 1988
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TAMBOCOR (FLECAINIDE ACETATE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLECAINIDE ACETATE
Proprietary Name: TAMBOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018830
Product Number: 001
Approval Date: Oct 31, 1985
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TAMBOCOR (FLECAINIDE ACETATE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLECAINIDE ACETATE
Proprietary Name: TAMBOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018830
Product Number: 003
Approval Date: Jun 3, 1988
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TAMBOCOR (FLECAINIDE ACETATE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLECAINIDE ACETATE
Proprietary Name: TAMBOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018830
Product Number: 002
Approval Date: Oct 31, 1985
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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