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Pharmaceutical industry / Food and Drug Administration / Pharmaceuticals policy / Abbreviated New Drug Application / New Drug Application / Generic drug / Structured Product Labeling / Federal Food /  Drug /  and Cosmetic Act / Medicine / Pharmaceutical sciences / Health


Levoleucovorin Calcium Injection, 10 mg (base)/mL; (175 mg (basemL and 250 mg (base)/25 mL Single-use Vials).
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Document Date: 2015-03-11 14:34:17


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City

West Princeton / /

Company

Spectrum Pharmaceuticals Inc. / ANDA APPROVAL Sandoz Inc. / Sandoz Inc. / /

Country

United States / /

Event

FDA Phase / Legal Issues / /

Facility

United States District Court / College Road West Princeton / /

IndustryTerm

federal law / discontinued drug products / active pharmaceutical ingredients / /

MedicalCondition

seizures / /

Organization

Regulatory Operations Office / Food and Drug Administration / Generic Drugs Center for Drug Evaluation and Research / Division of Bioequivalence / Research office of Prescription Drug Promotion / office of Prescription / Food and Drug Administration Center for Drug Evaluation / United States District Court for the District of Nevada / office of Generic Drugs / DEPARTMENT OF HEALTH / RPh Acting Deputy Director Office / /

Person

William P. Rickman / Silver Spring / Carol A. Holquist / Melissa Henry / /

Position

Director / Regulatory Affairs Dear Madam / /

Product

Calcium Injection / Fusilev Injection / Spectrum’s Fusilev Injection / Levoleucovorin / Federal Food / Approved Drug / Levoleucovorin Calcium Injection / Calcium / Fusilev / /

ProvinceOrState

New Jersey / Maryland / Nevada / /

PublishedMedium

Public Law / /

Technology

pdf / /

URL

http /

SocialTag