7_ANDA Checklist.pdfVIP

ANDA FILING CHECKLIST (CTD or eCTD FORMAT) FOR COMPLETENESS AND ACCEPTABILITY of an APPLICATION ANDA: APPLICANT: RELATED APPLICATION(S): DRUG NAME: DOSAGE FORM: LETTER DATE: RECEIVED DATE: P-IV FIRST GENERIC EXPEDITED REVIEW REQUEST: MaPP 5240.1 or MaPP 5240.3 (Approved/Denied) PEPFAR PET Electronic or Paper Submission: Type II DMF# BASIS OF SUBMISSION: NDA/ANDA: FIRM: RLD: **Document Room Note: for New Strength amendments and suppl