Acceptance for Filing definition

Acceptance for Filing means Atrix's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA pursuant to 21 CFR Section 314.101.

Acceptance for Filing means notification from the FDA indicating receipt of an NDA submission in the United States or equivalent marketing application pursuant to Applicable Laws in each country in the Territory.

Acceptance for Filing means that FDA has accepted the ANDA for the Product and an application number has been assigned by FDA to the ANDA.

Examples of Acceptance for Filing in a sentence

• The statement: "Date of Acceptance for Filing", which shall be the date the Department of Law files the plan.

• ER13-1957-001, ER13-1942-001, ER13-1946-001, ER13-1960-001, ER13-1947-001, and ER15-2200-000, Acceptance for Filing (November 19, 2015); see also ISO New England Inc., 151 FERC ¶ 61,133 (2015).

• Notwithstanding the foregoing, subject to Curis’ payment when due of the milestone payment for Acceptance for Filing of the first IND for a Product from the Licensed Program for PTP3, the Supplemental PTP3 Activities specifically exclude Aurigene’s Development Plan responsibilities and Phase 1 Trial supply obligations under Section 5.6 of the Agreement for such Licensed Program, the expenses of which are Aurigene’s sole responsibility under Section 5.4(b) of the Agreement.

• On February 2, 2017, IPCI filed a Form 6-K with the SEC attaching as Exhibit99.1 a press release entitled “Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista™ (oxycodone hydrochloride extended release), an Abuse Deterrent Analgesic for the Treatment of Moderate to Severe Pain” (the “February 2017 Press Release”).

• Common in Medieval Latin, this often creates uncertainty in the use of the accusative and ablative cases after prepositions.

More Definitions of Acceptance for Filing

Acceptance for Filing means Nycomed's receipt of a letter issued by the EMEA or other Competent Authority indicating acceptance for filing of a regulatory dossier pursuant to Applicable Laws in the Territory.

Acceptance for Filing means, with respect to an NDA filed for a Product: (a) in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. §314.101(a)(2) (or its successor regulation) that such NDA is officially “filed”; (b) in an EU Market, the receipt of written notice of acceptance for filing of such NDA from the EMA or the applicable national Regulatory Authority in such EU Market (as applicable); or (c) in Japan, the receipt of written notice of acceptance for filing of such NDA from the PMDA.

Acceptance for Filing means:

Acceptance for Filing means, with respect to an IND filed for a Product: (a) in the United States, the date the IND goes into effect in accordance with 21 C.F.R. §312.40(b) (or its successor regulation); or (b) in any other country or group of countries, after filing of an IND with the applicable Regulatory Authority for such country or group of countries, the date upon which enrollment of the first subject in the applicable clinical trial of such Product may legally occur in such country or group of countries.

Acceptance for Filing means GKI's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA or equivalent marketing application pursuant to Applicable Laws in a country in the Territory.

Acceptance for Filing means, following the submission of an application for Marketing Authorization made to a Regulatory Authority, the expiration of any applicable waiting period during which the Regulatory Authority has authority to issue a refusal to file, if any, as to such application.

Acceptance for Filing or “Accepted for Filing” shall mean, with respect to an MAA filed: (a) in a Major European Country, the receipt of written notice of acceptance for filing of such MAA from (i) the EMA or (ii) the applicable Regulatory Authority in the applicable Major European Country (as applicable); or (b) in China, the receipt of written notice of acceptance of filing of such MAA from the NMPA.