Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021301

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LEVOXYL (LEVOTHYROXINE SODIUM)
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 001
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 002
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 003
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 004
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 005
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 006
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 007
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 008
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 009
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: No
TE Code: AB1,AB3
Application Number: N021301
Product Number: 010
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
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: Yes
Reference Standard: Yes
TE Code: AB1,AB3
Application Number: N021301
Product Number: 011
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOXYL (LEVOTHYROXINE SODIUM)
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOXYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.3MG **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: N021301
Product Number: 012
Approval Date: May 25, 2001
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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