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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 201746

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NDA 201746 describes LINCOMYCIN, which is a drug marketed by Xgen Pharms and Watson Labs and is included in two NDAs. It is available from two suppliers. Additional details are available on the LINCOMYCIN profile page.

The generic ingredient in LINCOMYCIN is lincomycin hydrochloride. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lincomycin hydrochloride profile page.
Summary for 201746
Applicant:Xgen Pharms
Ingredient:lincomycin hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201746
Suppliers and Packaging for NDA: 201746
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINCOMYCIN lincomycin hydrochloride INJECTABLE;INJECTION 201746 ANDA X-GEN Pharmaceuticals, Inc. 39822-0350 39822-0350-2 10 VIAL in 1 CARTON (39822-0350-2) > 2 mL in 1 VIAL (39822-0350-1)
LINCOMYCIN lincomycin hydrochloride INJECTABLE;INJECTION 201746 ANDA X-GEN Pharmaceuticals, Inc. 39822-0353 39822-0353-6 10 mL in 1 VIAL (39822-0353-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 300MG BASE/ML
Approval Date:Jun 4, 2015TE:APRLD:No

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