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FDA Approval

Gemmily

CompanyXiromed, LLC (DUNS: 080228637)

Effective Date

July 12, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Registrants (1)

Xiromed Pharma Espana, S.L.

DUNS Number

468835741

Manufacturing Establishments (1)

Patheon Softgels Inc.

Labeler

Xiromed, LLC

Registrant

Xiromed Pharma Espana, S.L.

DUNS Number

002193829

Products (1)

Gemmily

NDC Product Code

70700-152

Application Number

ANDA213317

Marketing Category

ANDA (C73584)

Effective Date

July 12, 2023

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