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FDA Approval

Ceftriaxone Sodium

CompanyApotex Corp. (DUNS: 845263701)

Effective Date

January 28, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ceftriaxone(10 g in 1 1)

Registrants (1)

Qilu Pharmaceutical Co., Ltd.

DUNS Number

653878256

Manufacturing Establishments (2)

Qilu Pharmaceutical Co., Ltd.(High-Tech Zone Site)

Labeler

Apotex Corp.

Registrant

Qilu Pharmaceutical Co., Ltd.

DUNS Number

421279342

Qilu Antibiotics Pharmaceutical Co., Ltd.

Labeler

Apotex Corp.

Registrant

Qilu Pharmaceutical Co., Ltd.

DUNS Number

527271779

Products (1)

Ceftriaxone Sodium

NDC Product Code

60505-6150

Application Number

ANDA209218

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

September 23, 2019

Ingredients

CeftriaxoneActive

Code: 023Z5BR09KClass: ACTIMQuantity: 10 g in 1 1

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