aNDA

aNDA. Means an abbreviated new drug application or any equivalent of the foregoing, filed with the FDA and necessary for beginning the bioequivalence review trials for the use of Products in humans or any equivalent or similar application filed with the Regulatory Authorities of a country other than the United States prior to beginning bioequivalence review trials of the Products in humans in that country.

aNDA. An abbreviated new drug application filed with the FDA under section 505(j) of the Act (21 U.S.C. Section 355(j)), as amended and in effect from time to time. [***] [***] [***]

aNDA. Means either, and "ANDAs" means both, of the abbreviated new drug applications numbers 065055 and 065070 filed by Par and maintained by the ANDA Holder with the FDA for the manufacture and sale of the Product in the Territory, as the same may be supplemented and/or amended from time to time.

aNDA. Shall mean an Abbreviated New Drug Application filed with the FDA pursuant to 21 V.S.C. 355(j).

aNDA. Means an Abbreviated New Drug Application which contains data when submitted to U.S. FDA's center for Drug evaluation and Research, office of Generic Drugs, and provides for the review and ultimate approval of a generic drug product.

aNDA. Means Abbreviated New Drug Application.

aNDA. An Abbreviated New Drug Application filed with the FDA pursuant to 21 U.S.C. 355(j) and 21 C.F.R § 314.3, or any similar or successor statute or regulation.

aNDA. Means the Abbreviated New Drug Application Number 76-549 filed by Cobalt with the FDA on November 26, 2002.

aNDA. Means an Abbreviated New Drug Application and any supplements thereto.

aNDA. Means the Abbreviated New Drug Application #65-485 and any supplements or amendments thereto.