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 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.
Tentative Approval means, with respect to any Product, the tentative FDA Approval of the ANDA of Impax with respect to such Product.
Examples of Tentative Approval in a sentence
This procedure must be completed within one year, or the Tentative Approval will expire.
This procedure must be completed within one (1) 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.
Teva Announces Tentative Approval of Carvedilol Tablets, Business Wire (June 9, 2003).
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 shall be consistent with the Sierra County General Plan.
More Definitions of Tentative Approval
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
Tentative Approval means, as applicable, the tentative FDA approval of the Teva ANDA.
Tentative Approval means approval of the Handbook for the entire Project approved by the City Council pursuant to the Tentative Approval process under the Planned Development Law, resulting in a “Tentatively Approved Handbook.”
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 US. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the US.
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 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 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.