FDA.reportPublic FDA data

Application 210246

Type
ANDA
Sponsor
APOTEX

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
16714-536GlycopyrrolateGlycopyrrolateNORTHSTAR RX LLCANDACurrent
16714-536GlycopyrrolateGlycopyrrolateNORTHSTAR RX LLCANDACurrent
16714-620GlycopyrrolateGlycopyrrolateNORTHSTAR RX LLCANDACurrent
16714-620GlycopyrrolateGlycopyrrolateNORTHSTAR RX LLCANDACurrent
60505-6179GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6179GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6179GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6180GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6180GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6180GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6181GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6181GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6181GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6182GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6182GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
60505-6182GlycopyrrolateGlycopyrrolateApotex Corp.ANDACurrent
71872-7227GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent
71872-7237GlycopyrrolateGlycopyrrolateMedical Purchasing Solutions, LLCANDACurrent