Monday, October 2, 2023 10/2/2023

Comparability protocol for 22.5 mg tablets (NADA # 141-526)

Award Number: R01FD007800
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract The protocol is to add an additional strength of Laverdia tablets. Successful execution of this protocol will result in the addition of a 22.5 mg tablet to the existing portfolio of 2.5 mg, 10 mg and 50 mg tablets. There will be no changes to the manufacturing process or facility currently approved for Laverdia tablets. Approved analytical procedures will be used to assess and test the new tablet strength.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $250,000 )
2023	2023	ANIVIVE LIFESCIENCES, INC.	3250 AIRFLITE WAY # 400	LONG BEACH	CA	90807	LOS ANGELES	USA	Food and Drug Administration Research	000	1	12/7/2022	NEW	$250,000


Grand Total All Awards = $250,000

Sum of Action Amount is $250,000;

Grand Total = $250,000

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Comparability protocol for 22.5 mg tablets (NADA # 141-526)

Award Number: R01FD007800

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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