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Generated: November 21, 2018

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Details for New Drug Application (NDA): 064153

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NDA 064153 describes BACIIM, which is a drug marketed by X Gen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the BACIIM profile page.

The generic ingredient in BACIIM is bacitracin. There are twenty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bacitracin profile page.
Summary for 064153
Tradename:BACIIM
Applicant:X Gen Pharms
Ingredient:bacitracin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064153
Medical Subject Heading (MeSH) Categories for 064153
Suppliers and Packaging for NDA: 064153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACIIM bacitracin INJECTABLE;INJECTION 064153 ANDA X-GEN Pharmaceuticals, Inc. 39822-0277 39822-0277-5 10 VIAL in 1 CARTON (39822-0277-5) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0277-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50,000 UNITS/VIAL
Approval Date:May 9, 1997TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
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McKinsey
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Moodys
Merck
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