Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021410

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AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N021410
Product Number: 001
Approval Date: Oct 10, 2002
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N021410
Product Number: 002
Approval Date: Oct 10, 2002
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N021410
Product Number: 003
Approval Date: Oct 10, 2002
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM;EQ 2MG BASE **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: N021410
Product Number: 004
Approval Date: Aug 25, 2003
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDAMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM;EQ 4MG BASE **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: N021410
Product Number: 005
Approval Date: Aug 25, 2003
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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