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FDA Approval

Fulphila

CompanyBiocon Biologics Inc. (DUNS: 117609395)

Effective Date

December 5, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pegfilgrastim(6 mg in 0.6 mL)

Manufacturing Establishments (1)

Biocon Biologics Limited

Labeler

Biocon Biologics Inc.

DUNS Number

650501997

Products (1)

Fulphila

NDC Product Code

83257-005

Application Number

BLA761075

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS

Effective Date

December 5, 2023

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

PegfilgrastimActive

Code: 3A58010674Class: ACTIBQuantity: 6 mg in 0.6 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

POLYSORBATE 20Inactive

Code: 7T1F30V5YHClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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