FDA.reportPublic FDA data

Application 211705

Type
ANDA
Sponsor
CAPLIN

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
16714-906GlycopyrrolateGlycopyrrolateNorthStar Rx LLCANDACurrent
16714-906GlycopyrrolateGlycopyrrolateNorthStar Rx LLCANDACurrent
16714-906GlycopyrrolateGlycopyrrolateNorthStar Rx LLCANDACurrent
16714-998GlycopyrrolateGlycopyrrolateNorthStar Rx LLCANDACurrent
16714-998GlycopyrrolateGlycopyrrolateNorthStar Rx LLCANDACurrent
16714-998GlycopyrrolateGlycopyrrolateNorthStar Rx LLCANDACurrent
65145-102GlycopyrrolateGlycopyrrolateCaplin Steriles LimitedANDACurrent
65145-103GlycopyrrolateGlycopyrrolateCaplin Steriles LimitedANDACurrent
65145-104GlycopyrrolateGlycopyrrolateCaplin Steriles LimitedANDACurrent
65145-105GlycopyrrolateGlycopyrrolateCaplin Steriles LimitedANDACurrent
70069-011GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-012GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-013GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
70069-014GlycopyrrolateGlycopyrrolateSomerset Therapeutics, LLCANDACurrent
71288-407GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71288-407GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71288-407GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71288-408GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71288-408GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71288-408GlycopyrrolateGlycopyrrolateMeitheal Pharmaceuticals Inc.ANDACurrent
71839-123glycopyrrolateglycopyrrolateBE Pharmaceuticals Inc.ANDACurrent
71839-124glycopyrrolateglycopyrrolateBE Pharmaceuticals Inc.ANDACurrent
71839-125glycopyrrolateglycopyrrolateBE Pharmaceuticals Inc.ANDACurrent
71839-126glycopyrrolateglycopyrrolateBE Pharmaceuticals Inc.ANDACurrent