Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077337

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ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
500MG;EQ 2MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077337
Product Number: 001
Approval Date: May 7, 2014
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
500MG;EQ 1MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077337
Product Number: 005
Approval Date: May 19, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
500MG;EQ 4MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077337
Product Number: 002
Approval Date: May 7, 2014
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
1GM;EQ 4MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM;EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077337
Product Number: 004
Approval Date: May 7, 2014
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE)
1GM;EQ 2MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM;EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077337
Product Number: 003
Approval Date: May 7, 2014
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information