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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020357

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GLUCOPHAGE (METFORMIN HYDROCHLORIDE)
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOPHAGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020357
Product Number: 001
Approval Date: Mar 3, 1995
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
GLUCOPHAGE (METFORMIN HYDROCHLORIDE)
625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOPHAGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020357
Product Number: 003
Approval Date: Nov 5, 1998
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
GLUCOPHAGE (METFORMIN HYDROCHLORIDE)
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOPHAGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020357
Product Number: 004
Approval Date: Nov 5, 1998
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
GLUCOPHAGE (METFORMIN HYDROCHLORIDE)
850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOPHAGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 850MG **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: N020357
Product Number: 002
Approval Date: Mar 3, 1995
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
GLUCOPHAGE (METFORMIN HYDROCHLORIDE)
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUCOPHAGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM **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: N020357
Product Number: 005
Approval Date: Nov 5, 1998
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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