Can a drug have new drug application and an abbreviated new drug application number be the same?

What is the difference between ANDA and NDA?

NDA means New Drug Application. This application is available at the Food and Drug Administration (FDA). When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet the FDA's requirements for marketing approval, the sponsor submits to the FDA a new drug application (NDA). In other words, when a pharmaceutical company creates a new drug, the company must contact the FDA and demonstrate that the new drug has a particular quality and that the drug is safe and effective. In this case, the pharmaceutical company will have to fill out a new drug application (NDA). If the NDA is approved, then the product may be marketed in the United States. The application must contain data from specific technical viewpoints for review. The review is a comprehensive analysis of clinical trial data and other information prepared by the FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. For internal tracking purposes, all NDA applications are assigned an NDA number. The NDA number is a six-digit number assigned by the FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. ANDA means Abbreviated New Drug Application. This application is available at the Food and Drug Administration (FDA). An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the original drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. For internal tracking purposes, all ANDA applications are assigned an ANDA number. The ANDA number is a six-digit number assigned by the FDA staff to each application for approval to market a generic drug in the United States. A generic drug must be the same as the brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, the FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand-name drug. The FDA bases evaluations of substitutability or "therapeutic equivalence" of generic drugs on scientific evaluations.

Why is the word inches abbreviated?

For the same reason Kilogramme is abbreviated to Kg... to save space when writing or typing the measurement.

What is the abbreviated electron configuration for argon?

The abbreviated electron configuration for argon is [Ne] 3s^2 3p^6. The [Ne] represents the electron configuration of the noble gas neon, which has the same electron configuration as the inner electrons of argon.

Is it application software and application program the same?

Yes both are same

What is the difference between PH.D. and Ph.D?

Same degree, difference in the way you abbreviated it.

The application for approval of a generic equivalent of an existing proprietary drug must show that the drug?

C: is absorbed from the stomach into the bloodstream at the same rate as the proprietary drug I took this test 7/17/2009 :D B. Stomach I took this test 10/21/2010 (Correct answer)

Who may submit a drug license application?

Let's say you want to distribute pharmaceuticals or open a medical supply business and need a drug license. If so, you have to meet the educational requirements outlined in the 1940 Drugs and Cosmetic Act. A pharmacy degree is required of both competent individuals and pharmacists. The qualified individual needs to have prior drug distribution expertise. The pharmacist must maintain their registration with the Pharmacist Council at the same time. Since the Drug License Application will be submitted, they should have proof.

Does hyrdocodone show on a drug test the same as oxycodine?

yes, same drug basically

What medical abbreviation is the same as Hct?

Hct stands for hematocrit, which is sometimes abbreviated as crit.

Are duramine and metermine the same drug?

Yeah It is the same drug, My Doctor said Metermine is just another name that they use for the brand, It's the exact same drug.

What is drug test code number 763829?

I am looking for the same answer. I have been looking everywhere. Is your test through LabCorp too?

Will you pass a swab drug test if you passed a urine drug test on the same day?