Glycopyrrolate Injectable Solution

Brand(s)
Robinul
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cantrell Drug Company (2015-06-18)
Oldest Current Product
1975-02-06
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\GLYCOPYRROLATE
FDAOB
INJECTION\INJECTION\GLYCOPYRROLATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\GLYCOPYRROLATE
INTRAMUSCULAR\INJECTION, SOLUTION\GLYCOPYRROLATE
INTRAMUSCULAR\INJECTION\GLYCOPYRROLATE
INTRAVENOUS\INJECTION, SOLUTION\GLYCOPYRROLATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\GLYCOPYRROLATE
INTRAMUSCULAR\INJECTION, SOLUTION\GLYCOPYRROLATE
INTRAMUSCULAR\INJECTION, SOLUTION\GLYCOPYRRONIUM
INTRAMUSCULAR\INJECTION\GLYCOPYRROLATE
INTRAMUSCULAR\INJECTION\GLYCOPYRRONIUM
INTRAVENOUS\INJECTION, SOLUTION\GLYCOPYRRONIUM

product(s) by strength(s)

glycopyrrolate 0.2 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416034NDAWest-Ward Pharmaceuticals Corp.1975-02-06GLYCOPYRROLATEINTRAMUSCULARINJECTIONNDA01755861767a0d-c94c-44d8-b35c-316a5731a275
2006416036NDAWest-Ward Pharmaceuticals Corp.1975-02-06GLYCOPYRROLATEINTRAMUSCULARINJECTIONNDA01755861767a0d-c94c-44d8-b35c-316a5731a275
3006416104NDAWest-Ward Pharmaceuticals Corp.1975-02-06GLYCOPYRROLATEINTRAMUSCULARINJECTIONNDA01755838f88829-a226-4810-866c-1b62c47e8aee
4006416106NDAWest-Ward Pharmaceuticals Corp.1975-02-06GLYCOPYRROLATEINTRAMUSCULARINJECTIONNDA01755838f88829-a226-4810-866c-1b62c47e8aee
5525330028UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2014-06-25, 2014-08-05GLYCOPYRROLATEINTRAVENOUSINJECTION, SOLUTION0a019f04-b47f-4d4d-8202-bbc14de7955b, 74df1c5c-8aa5-4836-a1c8-a0888893732e, d48abe1d-5f3f-49ea-a31b-df39eef06821

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439584ANDAWest-Ward Pharmaceutical Corp2015-06-01GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963d5a18d74-0d40-46e2-aa0a-41d18609a536
2001439585ANDAWest-Ward Pharmaceutical Corp2015-06-01GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963d5a18d74-0d40-46e2-aa0a-41d18609a536
3001439586ANDAWest-Ward Pharmaceutical Corp2015-06-01GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963d5a18d74-0d40-46e2-aa0a-41d18609a536
4001439587ANDAWest-Ward Pharmaceutical Corp2015-06-01GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963d5a18d74-0d40-46e2-aa0a-41d18609a536
5001439679ANDAWest-Ward Pharmaceutical Corp2011-09-21GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963516cc4f8-3583-4405-ab66-29d4fcc56d05
6001439680ANDAWest-Ward Pharmaceutical Corp2011-09-21GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963516cc4f8-3583-4405-ab66-29d4fcc56d05
7001439681ANDAWest-Ward Pharmaceutical Corp2011-09-21GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963516cc4f8-3583-4405-ab66-29d4fcc56d05
8001439682ANDAWest-Ward Pharmaceutical Corp2011-09-21GLYCOPYRROLATEINTRAMUSCULARINJECTIONANDA090963516cc4f8-3583-4405-ab66-29d4fcc56d05
9005174601ANDAAmerican Regent, Inc.1990-09-30GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTIONANDA08933562267afe-1a73-4623-984e-646db590ec5b
10005174602ANDAAmerican Regent, Inc.1990-09-30GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTIONANDA08933562267afe-1a73-4623-984e-646db590ec5b
11005174605ANDAAmerican Regent, Inc.1990-09-30GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTIONANDA08933562267afe-1a73-4623-984e-646db590ec5b
12005174620ANDAAmerican Regent, Inc.1990-09-30GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTIONANDA08933562267afe-1a73-4623-984e-646db590ec5b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840009NDAGeneral Injecatables & Vaccines, Inc2010-03-01GLYCOPYRROLATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTION100190016NDA0175582ade57bf-4013-4358-9e3b-8b6df7fd4045
2525840107NDAGeneral Injecatables & Vaccines, Inc2012-10-11GLYCOPYRROLATEINTRAMUSCULARINJECTION006416107NDA0175582e17a1dd-5de0-4aa5-8985-c8dc02bf5a30
3525840155RobinulNDAGeneral Injecatables & Vaccines, Inc2010-08-01GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION609770155NDA0175583adddbd4-0b17-4312-83a2-a8420caf045e
4525840605ANDAGeneral Injecatables & Vaccines, Inc2012-02-20GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION005174605ANDA08933548b097ba-172f-4580-b08b-292706a905cd
5548680765NDAPhysicians Total Care, Inc.2011-05-06GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION100190016NDA017558d82ca14f-2116-4ec1-b497-1c9d6db4d5e7
6551542857NDACardinal Health2010-12-17GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION100190016NDA017558fe52214b-fe89-4215-a43b-5f9a85950fa9
7551542859NDACardinal Health2010-12-17GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION100190016NDA017558fe52214b-fe89-4215-a43b-5f9a85950fa9
8551542869NDACardinal Health2010-12-17GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION100190016NDA017558fe52214b-fe89-4215-a43b-5f9a85950fa9
9551542881NDACardinal Health1975-02-06GLYCOPYRROLATEINTRAMUSCULARINJECTION006416033NDA017558babc32fe-6454-4c16-b967-8432062db782
10551545722ANDACardinal Health2011-10-25GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION005174601ANDA089335125a2d5d-0ee6-4bd8-991d-5fbfbe3e7dcb
11551545737ANDACardinal Health2011-10-25GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION005174605ANDA089335125a2d5d-0ee6-4bd8-991d-5fbfbe3e7dcb
12551545739ANDACardinal Health2011-10-25GLYCOPYRROLATEINTRAMUSCULARINJECTION, SOLUTION005174602ANDA089335125a2d5d-0ee6-4bd8-991d-5fbfbe3e7dcb
13551547475ANDACardinal Health2011-09-21GLYCOPYRROLATEINTRAMUSCULARINJECTION001439682ANDA09096365688bed-0d70-4b51-8301-1948b1deade1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA081169GLYCOPYRROLATETrueTEVA PARENTERAL MEDICINES INC1991-09-10ANDA081169_001
2ANDA086947GLYCOPYRROLATETrueWATSON LABORATORIES INC1983-06-24ANDA086947_001
3ANDA088475GLYCOPYRROLATETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-06-12ANDA088475_001
4ANDA089335GLYCOPYRROLATELUITPOLD PHARMACEUTICALS INC1986-07-23ANDA089335_001
5ANDA089393GLYCOPYRROLATETrueHOSPIRA INC1988-06-15ANDA089393_001
6ANDA090963GLYCOPYRROLATEHIKMA FARMACEUTICA (PORTUGAL) SA2011-09-21ANDA090963_001
7NDA014764ROBINULTrueAH ROBINS CONDA014764_001
8NDA017558ROBINULEUROHEALTH INTERNATIONAL SARLNDA017558_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA081169_001discontinuedGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalse1991-09-10GLYCOPYRROLATE
2ANDA086947_001discontinuedGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalse1983-06-24GLYCOPYRROLATE
3ANDA088475_001discontinuedGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalse1984-06-12GLYCOPYRROLATE
4ANDA089335_001RXGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalseAP1986-07-23GLYCOPYRROLATE
5ANDA089393_001discontinuedGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalse1988-06-15GLYCOPYRROLATE
6ANDA090963_001RXGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalseAP2011-09-21GLYCOPYRROLATE
7NDA014764_001discontinuedGLYCOPYRROLATE (0.2MG/ML)INJECTIONFalseROBINUL
8NDA017558_001RXGLYCOPYRROLATE (0.2MG/ML)INJECTIONTrueAPROBINUL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10a019f04-b47f-4d4d-8202-bbc14de7955b (view SPL)Glycopyrrolate 0.2 mg/mL Injection Solution 5 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-08-053525330028
2125a2d5d-0ee6-4bd8-991d-5fbfbe3e7dcb (view SPL)GLYCOPYRROLATE INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-233551545722, 551545737, 551545739
32ade57bf-4013-4358-9e3b-8b6df7fd4045 (view SPL)Glycopyrrolate 0.2 mg/mL Injection, USP 5 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-252525840009
42e17a1dd-5de0-4aa5-8985-c8dc02bf5a30 (view SPL)ROBINUL Injection(glycopyrrolate injection, USP)NOT FOR USE IN NEONATESCONTAINS BENZYL ALCOHOLRx onlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-10-091525840107
538f88829-a226-4810-866c-1b62c47e8aee (view SPL)ROBINULInjection (glycopyrrolate injection, USP)prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2012-02-072006416104, 006416106, 006416105, 006416107
63adddbd4-0b17-4312-83a2-a8420caf045e (view SPL)Robinul (glycopyrrolate) 0.2 mg/mL Injection, USP 20 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-03-282525840155
748b097ba-172f-4580-b08b-292706a905cd (view SPL)Glycopyrrolate 0.2mg/mL 5ml multi-dose vialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-02-201525840605
8516cc4f8-3583-4405-ab66-29d4fcc56d05 (view SPL)GLYCOPYRROLATE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2013-04-012001439679, 001439680, 001439681, 001439682
961767a0d-c94c-44d8-b35c-316a5731a275 (view SPL)Glycopyrrolate Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2012-02-093006416034, 006416036, 006416033, 006416035
1062267afe-1a73-4623-984e-646db590ec5b (view SPL)GLYCOPYRROLATE INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2014-09-025005174601, 005174602, 005174605, 005174620
1165688bed-0d70-4b51-8301-1948b1deade1 (view SPL)GLYCOPYRROLATE INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-03-261551547475
1274df1c5c-8aa5-4836-a1c8-a0888893732e (view SPL)Glycopyrrolate 0.2 mg/mL Injection Solution 1 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-06-182525330028
13babc32fe-6454-4c16-b967-8432062db782 (view SPL)Glycopyrrolate Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-091551542881
14d48abe1d-5f3f-49ea-a31b-df39eef06821 (view SPL)Glycopyrrolate 0.2 mg/mL Injection Solution 2 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-08-051525330028
15d5a18d74-0d40-46e2-aa0a-41d18609a536 (view SPL)GLYCOPYRROLATE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-06-012001439584, 001439585, 001439586, 001439587
16d82ca14f-2116-4ec1-b497-1c9d6db4d5e7 (view SPL)Glycopyrrolate Injection, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-01-101548680765
17fe52214b-fe89-4215-a43b-5f9a85950fa9 (view SPL)Glycopyrrolate Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-04-192551542857, 551542859, 551542869

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