Application 207639

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATEINJECTABLE;INJECTION0.2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70069-011GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-011GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-011GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-011GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-012GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-012GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-012GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-012GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-013GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-013GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-013GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-013GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-014GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-014GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-014GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-014GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-616GLYCOPYRROLATEGLYCOPYRROLATESomerset Therapeutics, LLCANDACurrent
71872-7012GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7012GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7093GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7093GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7094GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7094GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48838ORIG2017-06-27