Chorionic Gonadotropin Injectable Solution

Brand(s)
Novarel, Pregnyl
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ferring Pharmaceuticals Inc. (2015-01-01)
Oldest Current Product
1974-01-15
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\CHORIONIC GONADOTROPIN
FDAOB
INJECTION\INJECTION\GONADOTROPIN, CHORIONIC\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CHORIOGONADOTROPIN ALFA
INTRAMUSCULAR\INJECTION\GONADOTROPHIN, CHORIONIC
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CHORIOGONADOTROPIN ALFA
INTRAMUSCULAR\INJECTION\GONADOTROPHIN, CHORIONIC

product(s) by strength(s)

chorionic gonadotropin 10000 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555661501NovarelNDAFerring Pharmaceuticals Inc.1974-01-15GONADOTROPHIN, CHORIONICINTRAMUSCULARINJECTIONNDA017016ac6918ff-9dc3-40d9-8619-54b26e4bdfc8
2633230025NDAApp Pharmaceuticals, Llc2011-04-21CHORIOGONADOTROPIN ALFAINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA017067f93b2baa-03ac-4650-b35a-20b818d712d6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684997PregnylNDAPhysicians Total Care, Inc.2010-08-17CHORIOGONADOTROPIN ALFAINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION000520315NDA017692dc604794-6dd6-43a7-85fa-2f04ed325c33

application(s)

#idtitledeprecatedapplicantapproved drug
1NDA017016CHORIONIC GONADOTROPINFERRING PHARMACEUTICALS INCNDA017016_004, NDA017016_006, NDA017016_007, NDA017016_009, NDA017016_010, NDA017016_011
2NDA017054CHORIONIC GONADOTROPINTrueBEL MAR LABORATORIES INCNDA017054_001, NDA017054_002
3NDA017055A.P.L.TrueFERRING PHARMACEUTICALS INCNDA017055_001, NDA017055_002, NDA017055_003
4NDA017056FOLLUTEINTrueBRISTOL MYERS SQUIBBNDA017056_001
5NDA017067CHORIONIC GONADOTROPINFRESENIUS KABI USA LLCNDA017067_001, NDA017067_002, NDA017067_003, NDA017067_004
6NDA017692PREGNYLORGANON USA INCNDA017692_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1NDA017016_004discontinuedGONADOTROPIN, CHORIONIC (20,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
2NDA017016_006discontinuedGONADOTROPIN, CHORIONIC (5,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
3NDA017016_007RXGONADOTROPIN, CHORIONIC (10,000 UNITS/VIAL)INJECTIONTrueAPCHORIONIC GONADOTROPIN
4NDA017016_009discontinuedGONADOTROPIN, CHORIONIC (2,000 UNITS/VIAL)INJECTIONFalse1984-12-27CHORIONIC GONADOTROPIN
5NDA017016_010discontinuedGONADOTROPIN, CHORIONIC (15,000 UNITS/VIAL)INJECTIONFalse1985-02-15CHORIONIC GONADOTROPIN
6NDA017016_011discontinuedGONADOTROPIN, CHORIONIC (2,000 UNITS/VIAL)INJECTIONFalse1990-02-16CHORIONIC GONADOTROPIN
7NDA017054_001discontinuedGONADOTROPIN, CHORIONIC (5,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
8NDA017054_002discontinuedGONADOTROPIN, CHORIONIC (10,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
9NDA017055_001discontinuedGONADOTROPIN, CHORIONIC (5,000 UNITS/VIAL)INJECTIONFalseA.P.L.
10NDA017055_002discontinuedGONADOTROPIN, CHORIONIC (10,000 UNITS/VIAL)INJECTIONFalseA.P.L.
11NDA017055_003discontinuedGONADOTROPIN, CHORIONIC (20,000 UNITS/VIAL)INJECTIONFalseA.P.L.
12NDA017056_001discontinuedGONADOTROPIN, CHORIONIC (10,000 UNITS/VIAL)INJECTIONFalseFOLLUTEIN
13NDA017067_001discontinuedGONADOTROPIN, CHORIONIC (5,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
14NDA017067_002RXGONADOTROPIN, CHORIONIC (10,000 UNITS/VIAL)INJECTIONTrueAPCHORIONIC GONADOTROPIN
15NDA017067_003discontinuedGONADOTROPIN, CHORIONIC (20,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
16NDA017067_004discontinuedGONADOTROPIN, CHORIONIC (15,000 UNITS/VIAL)INJECTIONFalseCHORIONIC GONADOTROPIN
17NDA017692_001RXGONADOTROPIN, CHORIONIC (10,000 UNITS/VIAL)INJECTIONTrueAPPREGNYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13e26b843-9c7a-4517-a1b6-9362aab0b86c (view SPL)Pregnyl (chorionic gonadotropin for injection USP)prescriptionHuman PrescriptionOrganon Usa Inc.API MANUFACTURE, MANUFACTURE, PACK2015-01-1610000520315
2ac6918ff-9dc3-40d9-8619-54b26e4bdfc8 (view SPL)Novarel(Chorionic Gonadotropin for Injection, USP)prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.API MANUFACTURE, MANUFACTURE2015-01-0120555661501
3dc604794-6dd6-43a7-85fa-2f04ed325c33 (view SPL)Pregnyl (chorionic gonadotropin for injection, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-04-191548684997
4f93b2baa-03ac-4650-b35a-20b818d712d6 (view SPL)Chorionic Gonadotropin For Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-04-201633230025

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