USFDA APPLICATION NUMBER - 12827 / DOSAGE - TABLET;ORAL - 2MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
GLYCOPYRROLATE(UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) | GLYCOPYRROLATE | 2mg | 1mg |
Inactive Ingredients
Ingredient Name | American Health Packaging | AvKARE, Inc. | Bryant Ranch Prepack | Leading Pharma, LLC | Major Pharmaceuticals | Mylan Institutional Inc. | Avera McKennan Hospital | Cardinal Health | Qualitest Pharmaceuticals | REMEDYREPACK INC. | Shionogi Inc. | NCS HealthCare of KY, Inc dba Vangard Labs | APPCO PHARMA LLCC | REMEDYREPACK INC. |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | ||||||||||||||
ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||||||||
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J) | ||||||||||||||
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP) | ||||||||||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP) | ||||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||
LACTOSE(J2B2A4N98G) | ||||||||||||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||||||||||||||
MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||
POVIDONE(FZ989GH94E) | ||||||||||||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||||||
POVIDONES(FZ989GH94E) | ||||||||||||||
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) |
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