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Endura

REFRESH ENDURA

Approved
Approval ID

bbbbab91-5f9d-42d5-87fc-d629da20e8b1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 26, 2019

Manufacturers
FDA

Allergan, Inc.

DUNS: 144796497

Products 1

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

Glycerin and Polysorbate 80

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0023-9235
Product Classification
G
Generic Name
Glycerin and Polysorbate 80
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 17, 2023
FDA Product Classification

INGREDIENTS (7)

POLYSORBATE 80Active
Quantity: 1 g in 100 mL
Code: 6OZP39ZG8H
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINActive
Quantity: 1 g in 100 mL
Code: PDC6A3C0OX
Classification: ACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 71DD5V995L
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT

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Endura - FDA Drug Approval Details