FDA.reportPublic FDA data

Application 017530

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIGANTRIMETHOBENZAMIDE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9964TiganTrimethobenzamide HydrochlorideHenry Schein, IncNDACurrent
0404-9964TiganTrimethobenzamide HydrochlorideHenry Schein, IncNDACurrent
21695-853Tigantrimethobenzamide hydrochlorideRebel Distributors CorpNDACurrent
42023-118Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
42023-118Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
42023-119Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
42023-119Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
51662-1430TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1430TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1430TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11013SUPPL2008-06-05
13831SUPPL2008-04-22
40746SUPPL2007-07-09
33292SUPPL2005-08-31
13830SUPPL2005-08-31
11012SUPPL2005-08-31
11011SUPPL2005-08-31
618SUPPL2005-08-31
617SUPPL2005-08-31
13168SUPPL2004-06-18
11010SUPPL2004-06-18