Hyaluronidase Injectable Solution

Brand(s)
Amphadase, Vitrase
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amphastar Pharmaceuticals, Inc. (2015-05-19)
Oldest Current Product
2004-10-26
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\HYALURONIDASE
FDAOB
INJECTION\INJECTION\HYALURONIDASE\rdfq
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\HYALURONIDASE, OVINE
SUBCUTANEOUS\INJECTION\HYALURONIDASE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\HYALURONIDASE, OVINE
SUBCUTANEOUS\INJECTION\HYALURONIDASE

product(s) by strength(s)

hyaluronidase 150 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005489090AmphadaseNDAAmphastar Pharmaceuticals, Inc.2004-10-26HYALURONIDASESUBCUTANEOUSINJECTIONNDA0216658396ea96-7cb5-4e26-87a4-90bca9c3c6dd

hyaluronidase 200 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080002VitraseNDABausch & Lomb Incorporated2005-02-01HYALURONIDASE, OVINESUBCUTANEOUSINJECTION, SOLUTIONNDA02164021fbd12e-4a12-4ad1-ad01-964cd5ec9996, c1e7f7be-2631-42a6-9cfb-7249c93a90f1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA006343WYDASETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARENDA006343_002, NDA006343_005, NDA006343_006
2NDA021640VITRASEBAUSCH AND LOMB INC2004-05-05NDA021640_001, NDA021640_002
3NDA021665AMPHADASEAMPHASTAR PHARMACEUTICAL INC2004-10-26NDA021665_001
4NDA021716HYDASETrueAKORN INC2005-10-25NDA021716_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA006343_002discontinuedHYALURONIDASE (150 UNITS/ML)INJECTIONFalseWYDASE
2NDA006343_005discontinuedHYALURONIDASE (1,500 UNITS/VIAL)INJECTIONFalseWYDASE
3NDA006343_006discontinuedHYALURONIDASE (150 UNITS/VIAL)INJECTIONFalseWYDASE
4NDA021640_001discontinuedHYALURONIDASE (6,200 UNITS/VIAL)INJECTIONFalse2004-05-05VITRASE
5NDA021640_002RXHYALURONIDASE (200 UNITS/VIAL)INJECTIONTrue2004-12-02VITRASE
6NDA021665_001RXHYALURONIDASE (150 UNITS/ML)INJECTIONTrue2004-10-26AMPHADASE
7NDA021716_001discontinuedHYALURONIDASE (150 UNITS/ML)INJECTIONFalse2005-10-25HYDASE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
121fbd12e-4a12-4ad1-ad01-964cd5ec9996 (view SPL)These highlights do not include all the information needed to use VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mL safely and effectively. See full prescribing information for VITRASE. VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mLInitial U.S. Approval: 2004prescriptionHuman PrescriptionBausch & Lomb IncorporatedANALYSIS, LABEL, MANUFACTURE, PACK2014-10-011242080002
28396ea96-7cb5-4e26-87a4-90bca9c3c6dd (view SPL)These highlights do not include all the information needed to use AMPHADASE safely and effectively. See full prescribing information for AMPHADASE. Amphadase (hyaluronidase injection) Initial U.S. Approval: 2005prescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.analysis, manufacture2015-05-196005489090
397474ce2-df07-41fb-84ca-3ff35ec578e7 (view SPL)These highlights do not include all the information needed to use VITRASE (hyaluronidase injection) Ovine, 200 USP/mL safely and effectively. See full prescribing information for VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mL. VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mLInitial U.S. Approval: 2004prescriptionHuman PrescriptionIsta Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2012-05-215674250002
4c1e7f7be-2631-42a6-9cfb-7249c93a90f1 (view SPL)These highlights do not include all the information needed to use VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mL safely and effectively. See full prescribing information for VITRASE. VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mLInitial U.S. Approval: 2004prescriptionHuman PrescriptionBausch & Lomb IncorporatedANALYSIS, LABEL, MANUFACTURE, PACK2012-10-016242080002

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII