Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Pegasus Laboratories, Inc.
108454760
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pegasus Laboratories, Inc.
Pegasus Laboratories, Inc.
Pegasus Laboratories, Inc.
108454760
Cheng Fong Chemical Co Ltd
Pegasus Laboratories, Inc.
Pegasus Laboratories, Inc.
658828116
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PhenylPro 25
Product Details
NDC Product Code
49427-920Application Number
NADA141324Marketing Category
NADA (C73593)Route of Administration
ORALEffective Date
April 18, 2025STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SOY PROTEINInactive
Code: R44IWB3RN5Class: IACT
YEASTInactive
Code: 3NY3SM6B8UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
WHEYInactive
Code: 8617Z5FMF6Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
GARLICInactive
Code: V1V998DC17Class: IACT
PhenylpropanolamineActive
Code: 8D5I63UE1QClass: ACTIBQuantity: 25 1 in 1 1