Actavis ANDA definition

Actavis ANDA means ANDA No. 206210 (together with any amendments, supplements, replacements or other changes thereto) seeking approval to engage in the Manufacture, use and sale of an extended release oral capsule product containing the Compound as its sole active ingredient.
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Actavis ANDA means ANDA No. 204982, including all amendments, supplements and Replacements thereto as may be required by the FDA in order to obtain FDA approval thereof.
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Actavis ANDA means ANDA No. 207338 as of the Effective Date and any later filed amendments, supplements or replacements thereto seeking *** Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2 approval of a generic product that is AB-Rated to Abstral, excluding additions or substitutions of ingredients which constitute a major amendment to ANDA No. 207338, or if post approval, the addition or substitution requires FDA approval pursuant 21 CFR 314.70(b).
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Examples of Actavis ANDA in a sentence

  • The Board must notify PSAPs of the estimated distributions no later than December 31 of each year.

  • In the absence of such information, Plaintiffs resort to the judicial process and the aid of discovery to obtain, under appropriate judicial safeguards, such information as is required to confirm their allegations of infringement and to present to the Court evidence that the Actavis ANDA Product falls within the scope of one or more claims of each of the patents-in-suit.

  • On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act, ANDA No. 208043 includes a certification that the claims the patents-in-suit are invalid, unenforceable, or would not be infringed by the commercial manufacture, use or sale of the Actavis ANDA Product.

  • Id. at 730:7-731:1.It is undisputed that the Actavis ANDA product passed blend uniformity testing.

  • The limited information contained within the Notice Letter does not demonstrate that the Actavis ANDA Product fails to fall within the scope of at least one claim in each of the patents-in-suit.

  • This data simply reflected the MHD levels over time in the subjects after one dose of the Actavis ANDA product.

  • He concluded, therefore, that the MHD steady state blood level for this dose of the Actavis ANDA product falls within the limitations of Claim 6 of the ’898 and ’131 Patents.

  • On the basis of the records seen and information provided, a notable fact about Mrs B is the minimal information obtained by any of the agencies involved with her care about her family and her relationships that might impact on her wellbeing and on her care and support.

  • PTX 170.3; PTX 572.3. Dr. Little reviewed the results of blend uniformity testing as found in the Actavis ANDA and concluded that the Actavis Tablets are uniform.

  • In addition, there are incorrect “buggy” solution paths that the cognitive model recognizes.


More Definitions of Actavis ANDA

Actavis ANDA means Actavis’s ANDA No. 209253 as supplemented and amended as of the Execution Date of this License Agreement and including any Permitted Modification after the Execution Date of this License Agreement.
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Actavis ANDA means Actavis’ ANDA No. 205063 and any amendments, supplements or replacements thereto, so long as there is no change to the active ingredient, dosage form, Reference Listed Drug or AB rating or the label (except to meet statutory or express FDA requirements) of the Actavis Generic Product as defined herein as of the Execution Date of this License Agreement.
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Related to Actavis ANDA

  • Subco means 1102209 B.C. LTD., a corporation incorporated under the laws of the Province of British Columbia;

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • Acquisition Subsidiary shall have the meaning ascribed to it in the preamble hereto.

  • parent mixed financial holding company in a Member State means a mixed financial holding company which is not itself a subsidiary of an institution authorised in the same Member State, or of a financial holding company or mixed financial holding company set up in that same Member State;

  • Representative of the news media means any person actively gathering news for an entity that is organized and operated to publish or broadcast news to the general public.

  • Related Financial Product means any financial product which references directly or indirectly the Preference Shares.

  • Holding Company Transaction means the occurrence of (a) any transaction (including, without limitation, any acquisition, merger or consolidation) the result of which is that a “person” or “group” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended, (i) becomes the direct or indirect ultimate “beneficial owner,” as defined in Rule 13d-3 under that Act, of common equity of the Issuer representing more than 50% of the voting power of the outstanding Common Stock or (ii) is otherwise required to consolidate the Issuer for purposes of generally accepted accounting principles in the United States, or (b) any consolidation or merger of the Issuer or similar transaction or any sale, lease or other transfer in one transaction or a series of related transactions of all or substantially all of the consolidated assets of the Issuer and its subsidiaries, taken as a whole, to any Person other than one of the Issuer’s subsidiaries; provided that, in the case of either clause (a) or (b), the Issuer or the Acquiror is or becomes a Bank Holding Company or Savings and Loan Holding Company.

  • Member of the University Community means students, faculty, or staff, or other persons affiliated with the University.

  • CCC means Customer Care Centre

  • mixed financial holding company means a mixed financial holding company as defined in point (21) of Article 4(1) of Regulation (EU) No 575/2013;

  • Ambulatory surgical facility means a facility that:  Is licensed by the state where it is located.  Is equipped and operated mainly to provide for surgeries or obstetrical deliveries.  Allows patients to leave the facility the same day the surgery or delivery occurs.

  • Dialysis solution means either the commercially available, unopened, sterile solutions whose

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • CTS means the market rules that allow transactions to be scheduled based on a bidder’s willingness to purchase energy from a source in either the NYISO or PJM Control Area and sell it at a sink in the other Control Area if the forecasted price at the sink minus the forecasted price at the corresponding source is greater than or equal to the dollar value specified in the bid.

  • Bidco means a business and industrial development company licensed under this act. The term includes a business development enterprise.

  • Eligible next Michigan business means that term as defined in section 3 of the Michigan economic growth authority act, 1995 PA 24, MCL 207.803.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • CMBI means Chase Manhattan Bank International, an indirect wholly-owned subsidiary of Bank, located in Moscow, Russia, and any nominee companies appointed by it.

  • Successor Holdings has the meaning assigned to such term in Section 6.03(a)(v).

  • Apex means a point on an alluvial fan or similar landform below which the flow path of the major stream that formed the fan becomes unpredictable and alluvial fan flooding can occur.

  • Natural uranium means uranium with the naturally occurring distribution of uranium isotopes, which is approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238.

  • Spectrum means frequencies of electromagnetic spectrum used to provide fixed or mobile communications services as licensed or authorized by the FCC.

  • Acquiring Company means a person who obtains Control of the Company;

  • parent financial holding company in a Member State means a financial holding company which is not itself a subsidiary of an institution authorised in the same Member State, or of a financial holding company or mixed financial holding company set up in the same Member State;

  • OPWC means the Ohio Public Works Commission created pursuant to Revised Code Section 164.02.

  • Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.