The following Structured Product Label (SPL) was submitted to the FDA by Gland Pharma Limited for the product Olopatadine Hydrochloride Ophthalmic Solution (NDC 68083-398). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
BULK LABEL
NDC 68083-398-85
Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.7%.
Quantity- 1,000 - 2.5 mL fill Bottles
Batch No. : AXXXXXXX
Exp. Date : MM/YYYY
Store at 2°-25°C (36°-77°F)
CAUTION: For Manufacturing, processing or repackaging only.
Manufactured by :
Gland Pharma Limited
D.P. Pally, Hyderabad - 500043, INDIA
Code: AP/DRUGS/103/97
Olopatadine-bulk (Olopatadine Bulk)
* Please review the disclaimer below.
