ANDA definition

ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

ANDA. ANDA shall mean any of the following: (a) an Abbreviated New Drug Application filed with the FDA or any successor applications or procedures; (b) any counterpart of a U.S. Abbreviated New Drug Application or any successor applications or procedures that may be filed with the EMEA, MHLW or other Regulatory Authority outside of the United States, and (c) all supplements and amendments that may be filed with respect to the foregoing.

ANDA means abbreviated new drug application.

Examples of ANDA in a sentence

• Your ANDA identifies at least one facility that is subject to the self- identification requirement and payment of an annual facility fee.

• It should also identify changes, if any, in the conditions under which the ANDA was tentatively approved, e.g., updated information such as final-printed labeling, chemistry, manufacturing, and controls data as appropriate.

• Your ANDA identifies at least one facility that is subject to the self-identification requirement and payment of an annual facility fee.

• RESUBMISSION To request final approval, please submit an amendment titled “FINAL APPROVAL REQUESTED” with enough time to permit FDA review prior to the date you believe that your ANDA will be eligible for final approval.

• The Agency is assured there is no new information that would affect whether final approval should be granted.Please note that if FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for a listed drug, an ANDA citing that listed drug also will be required to have a REMS.

More Definitions of ANDA

ANDA means an Abbreviated New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA.

ANDA means an Abbreviated New Drug Application, or similar application for marketing approval of a Product submitted to the FDA.

ANDA means an Abbreviated New Drug Application pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3.

ANDA means an Abbreviated New Drug Application filed pursuant to the requirements of the FDA, or the equivalent application in any other country or jurisdiction, required before Commercial Sale of a drug product.

ANDA means an Abbreviated New Drug Application and any supplements thereto.

ANDA means an Abbreviated New Drug Application.

ANDA means an Abbreviated New Drug Application as defined in the Act.