Product Details for NDA 021292
EUTHYROX (LEVOTHYROXINE SODIUM)
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
0.3MG
Marketing Status: Discontinued
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 001
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 001
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 002
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 002
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 003
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 003
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 004
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 004
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 005
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 005
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 006
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 006
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 007
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 007
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 008
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 008
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 009
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 009
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 010
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 010
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 011
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EUTHYROX (LEVOTHYROXINE SODIUM)
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N021292
Product Number: 011
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.3MG
Marketing Status: Discontinued
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.3MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021292
Product Number: 012
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: EUTHYROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.3MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021292
Product Number: 012
Approval Date: May 31, 2002
Applicant Holder Full Name: PROVELL PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information