NDA

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Related to New drug application: abbreviated new drug application

NDA

(Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any other purpose. NDAs are signed for myriad reasons including when source code is handed to another party for modification or when a new product under development is being reviewed by the press, a prospective customer or other party.
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References in periodicals archive ?
Abbott Laboratories and Forest Pharmaceuticals, manufacturer of Levothroid, filed New Drug Applications in August but had not received approval at press time.
The United States Food and Drug Administration (FDA) has received a New Drug Application (NDA) seeking approval for Israel-based Foamix Pharmaceuticals Ltd's (Nasdaq: FOMX) FMX103 intended for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older, it was reported yesterday.
Recently the FDA accepted Discovery's New Drug Application for Surfaxin for the prevention of RDS in premature infants and has granted a PDUFA date of February 13, 2005.
The multiple components of the overall process including discovery, efficacy testing, development of lead agents, toxicology and pharmacology, investigational new drug application filing, and clinical evaluation may require years and several million dollars.
On October 3, 2001, the committee will discuss new drug application (NDA) 21-356, for Viread[TM], (tenofovir disoproxil fumarate) Tablets, proposed for the treatment of Human Immunodeficiency Virus (HIV) infection.
M2 PHARMA-July 29, 2019-US FDA accepts Epizyme's Tazemetostat New Drug Application for filing
M2 EQUITYBITES-July 29, 2019-US FDA accepts Epizyme's Tazemetostat New Drug Application for filing
Tokyo, Japan, Nov 30, 2006 - (JCN) - Toray, JT and Torii Pharmaceutical announced November 28 that the companies have filed for a new drug application in Japan for TRK-820, an antipruritic agent originally discovered by Toray.
The United States Food and Drug Administration (FDA) has received a new drug application (NDA) from United States-based Epizyme for accelerated approval of Tazemetostat intended for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, it was reported on Friday.
SpecGx, a subsidiary of Mallinckrodt that operates its specialty generics business, announced that it has received a complete response letter, or CRL, from the FDA related to its new drug application, or NDA, for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Going forward, Beijing Tide Pharmaceutical will conduct clinical trials in China and file a new drug application in 2007.
It was reported yesterday that United States-based Kala Pharmaceuticals has submitted a new drug application for its KPI-121 0.25% product candidate to the US Food and Drug Administration (USFDA).