Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 010379

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CYTOMEL (LIOTHYRONINE SODIUM)
EQ 0.005MG BASE
Marketing Status: Prescription

Active Ingredient: LIOTHYRONINE SODIUM
Proprietary Name: CYTOMEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.005MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010379
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYTOMEL (LIOTHYRONINE SODIUM)
EQ 0.025MG BASE
Marketing Status: Prescription

Active Ingredient: LIOTHYRONINE SODIUM
Proprietary Name: CYTOMEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.025MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010379
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYTOMEL (LIOTHYRONINE SODIUM)
EQ 0.05MG BASE
Marketing Status: Prescription

Active Ingredient: LIOTHYRONINE SODIUM
Proprietary Name: CYTOMEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.05MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010379
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information