To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)

Key Inclusion Criteria:

• Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
• Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
• Have an IGA score of 3 (moderate) or 4 (severe).
• Have an affected Body Surface Area (BSA) of at least 20% at baseline.
• Treated with a bland emollient for at least 7 days.

Key Exclusion Criteria:

• Active cutaneous bacterial or viral infection in any treatment area at baseline.
• Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
• History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
• History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
• Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.