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FDA Approval

polycin

CompanyRPK Pharmaceuticals, Inc. (DUNS: 147096275)

Effective Date

June 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Polymyxin B(10000 [USP'U] in 1 g)

Bacitracin(500 [USP'U] in 1 g)

Manufacturing Establishments (1)

RPK Pharmaceuticals, Inc.

Labeler

RPK Pharmaceuticals, Inc.

DUNS Number

147096275

Products (1)

polycin

NDC Product Code

53002-9270

Application Number

ANDA065022

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

November 12, 2018

Ingredients

Polymyxin BActive

Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 g

BacitracinActive

Code: 89Y4M234ESClass: ACTIMQuantity: 500 [USP'U] in 1 g

PETROLATUMInactive

Code: 4T6H12BN9UClass: IACT

MINERAL OILInactive

Code: T5L8T28FGPClass: IACT

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