Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.
Tentative Approval means, with respect to any Product, the tentative FDA Approval of the ANDA of Impax with respect to such Product.
Tentative Approval means the approval granted by the Authority pursuant to the requirements as specified in Section 105 and which does not constitute a reservation of capacity or service from the Authority but shall signify that upon submission of a request for Final Approval and compliance with the requirements as specified in Section 105, final Approval may be granted by the Authority.
Examples of Tentative Approval in a sentence
The average density for any subdivision of property made by Tentative Approval pursuant to the Subdivision Map Act occurring after the effective date of this Policy and implemented under Tier 1 shall not exceed the allowable density values in Table 1 for a single-family dwelling unit, or its equivalent, for those units that rely on OWTS.
This procedure must be completed within one year, or the Tentative Approval will expire.
Motion: To approve the following budget schedule for 2021, as recommended by the Finance Committee: 8/24 Meeting - Review Budget - Tentative Approval 9/14 Meeting - Public Hearing - Final Approval.
This procedure must be completed within one (1) year, or the Tentative Approval will expire.
Certificate of Tentative Approval vesting extension shall expire and be null and void on , 20 Secretary.
More Definitions of Tentative Approval
Tentative Approval means, as applicable, the tentative FDA approval of the Teva ANDA.
Tentative Approval means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval for marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase and use outside the United States under PEPFAR. As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications. This is a generic formulation of Combivir Tablets, 150 mg/300 mg, a product of VIIV HealthcareC ompany, which is subject to patent protection in the United States.
Tentative Approval means that FDA has concluded that a drug producthasmetallrequiredquality, safetyandefficacystandards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.
Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. The tentative approval will be eligible for conversion to a final approval subject to the resolution of the current patent litigation between Eagle and Eli Lilly and Co.
Tentative Approval means that the proposed generic has been deemed by the FDA to be safe, effective and bioequivalent to its brand name counterpart, but the existence of some unexpired legal or regulatory barrier (such as Orphan Drug exclusivity) precludes the FDA from granting final approval. Put another way, the approval would be final and not “tentative” but for the unexpired regulatory exclusivity.
Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, butbecauseofexistingpatentsand/orexclusivityrights, itcannotyet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.
Tentative Approval means that although existing patents and/or marketing exclusivity prevent the ap- proval of the product in the United States at this time, the product meets all of the FDA’s normal requirements for manufacturing quality and clini- cal safety and efficacy. The agency says it performs all of its reviews of applications received in association with the Emergency Plan on an expe- dited basis; the agency reviewed this application for lamivudine tablets in