Service | US - ANDA
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's
Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), provides for
the review and ultimate approval of a generic drug product. Once approved, an applicant may
manufacture and market the generic drug product to provide a safe, effective, low cost
alternative to the American public. A generic drug product is one that is comparable to an
innovator drug product in dosage form, strength, and route of administration, quality,
performance characteristics and intended use.

NUVO assist its clients in preparation and submission of ANDA in eCTD with SPL R4 assistance.
NUVO can undertake but not limited to following activities for ANDA
Module 1: Preparation and assistance for finalizing Administrative and prescribing
Module 2 : Summaries and overviews by expert for Quality, clinical and nonclinical.
Module 3, 4 and 5: Dossier writing for all the three modules (module 3, module 4 and
module 5) for generic products as per CTD format.
QbR preparation as per guidance.
Query response assistance
QbR preparation as per guidance.
Final compilation of CTD modules in eCTD format.
Preparation of structured product labeling (SPL) in R4 eDRLS as per US FDA
Assistance in reply queries and complete lifecycle management activities like Annual
updates, Amendments and supplements, Changes to ANDA.
Gap Analysis of dossier with suitable solutions to make it approvable.
Guidance on Generic drug user fees Act (GDUFA)  (new)
Self identification filings with FDA as per GDUFA. (new)
Applications for Establishment registrations, labeler code  and drug listing for USA
Obtaining NDC codes.
DUNS no. applications
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