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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018343

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CAPOTEN (CAPTOPRIL)
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018343
Product Number: 005
Approval Date: Jan 17, 1985
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CAPOTEN (CAPTOPRIL)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018343
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CAPOTEN (CAPTOPRIL)
37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018343
Product Number: 006
Approval Date: Sep 17, 1986
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CAPOTEN (CAPTOPRIL)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
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: N018343
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CAPOTEN (CAPTOPRIL)
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG **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: N018343
Product Number: 007
Approval Date: Jun 13, 1995
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CAPOTEN (CAPTOPRIL)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
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: N018343
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
CAPOTEN (CAPTOPRIL)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CAPTOPRIL
Proprietary Name: CAPOTEN
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: N018343
Product Number: 004
Approval Date: Jun 13, 1995
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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