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FDA Approval

Endura

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

FDA Approval Summary

Company
Allergan, Inc.
DUNS: 144796497
Effective Date
November 26, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Polysorbate 80(1 g in 100 mL)
Glycerin(1 g in 100 mL)

Products1

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

Endura

Product Details

NDC Product Code
0023-9235
Route of Administration
OPHTHALMIC
Effective Date
January 17, 2023
Code: 6OZP39ZG8HClass: ACTIBQuantity: 1 g in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GlycerinActive
Code: PDC6A3C0OXClass: ACTIBQuantity: 1 g in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 71DD5V995LClass: IACT
CASTOR OILInactive
Code: D5340Y2I9GClass: IACT
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