MedPath
FDA Approval

Ceftriaxone Sodium

August 31, 2023

HUMAN PRESCRIPTION DRUG LABEL

Ceftriaxone(2 g in 1 1)

Registrants (1)

Qilu Pharmaceutical Co., Ltd.

653878256

Manufacturing Establishments (2)

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

Apotex Corp.

Qilu Pharmaceutical Co., Ltd.

421279342

Qilu Antibiotics Pharmaceutical Co., Ltd.

Apotex Corp.

Qilu Pharmaceutical Co., Ltd.

527271779

Products (4)

Ceftriaxone Sodium

60505-6149

ANDA203702

ANDA (C73584)

INTRAVENOUS, INTRAMUSCULAR

August 31, 2023

Code: 023Z5BR09KClass: ACTIMQuantity: 2 g in 1 1

Ceftriaxone Sodium

60505-6148

ANDA203702

ANDA (C73584)

INTRAVENOUS, INTRAMUSCULAR

August 31, 2023

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

Ceftriaxone Sodium

60505-6152

ANDA203702

ANDA (C73584)

INTRAMUSCULAR, INTRAVENOUS

August 31, 2023

Code: 023Z5BR09KClass: ACTIMQuantity: 500 mg in 1 1

Ceftriaxone Sodium

60505-6151

ANDA203702

ANDA (C73584)

INTRAMUSCULAR, INTRAVENOUS

August 31, 2023

Code: 023Z5BR09KClass: ACTIMQuantity: 250 mg in 1 1
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