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Liothyronine Sodium

These highlights do not include all the information needed to use LIOTHYRONINE SODIUM TABLETS, USP safely and effectively. See full prescribing information for LIOTHYRONINE SODIUM TABLETS, USP. LIOTHYRONINE SODIUM TABLETS, USP, for oral use Initial U.S. Approval: 1956

Approved
Approval ID

7efdd16d-37e6-4dc8-a6c5-5b42c4813379

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 21, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Liothyronine Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71335-0166
Application NumberANDA200295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Liothyronine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2019
FDA Product Classification

INGREDIENTS (6)

GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LIOTHYRONINE SODIUMActive
Quantity: 25 ug in 1 1
Code: GCA9VV7D2N
Classification: ACTIM

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Liothyronine Sodium - FDA Drug Approval Details