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FDA Approval

Ticagrelor

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 7, 2025
Labeling Type
Human Prescription Drug Label
Ticagrelor(90 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Inc.

650574671

Products1

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

Ticagrelor

Product Details

NDC Product Code
62332-241
Application Number
ANDA208576
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 7, 2025
Code: GLH0314RVCClass: ACTIBQuantity: 90 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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