Application 089397

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATEInjectable; Injection0.2MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEQUAGEN PHARMACEUTICALS LLC62e1ba35-bc84-4818-be54-8b534a1bf93c2026-09-10Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c2026-09-09Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.4ecb3435-58e5-46cb-b8c2-85b5fd955f832026-09-09Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLC1f266d77-4f9e-44c9-a000-2f8fea3ac80b2026-07-09Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEAmneal Pharmaceuticals LLCbbab4cf1-0441-4fc4-9de9-e4117fa19faa2026-07-07Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEPiramal Critical Care Inc83d70378-011b-4ce3-e053-2991aa0a22be2026-06-23Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATECardinal Health 107, LLC65688bed-0d70-4b51-8301-1948b1deade12026-06-02Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEREMEDYREPACK INC.220cd5f5-3d71-4fdb-9943-7468799c179f2026-06-02Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEGolden State Medical Supply, Inc.ec15e70c-8473-469a-9f07-ea668783fa072026-05-27Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEMeitheal Pharmaceuticals Inc.02541cfd-b209-49b9-a73f-13ef18dce06d2026-05-20Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLCff65c5d3-7ba9-4315-a884-199151eb45a52026-05-14Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack098c7654-a352-47ee-bf23-6a81f86012662026-05-05Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEAtlantic Biologicals Corp.50b493d7-8e3b-e459-e063-6394a90addbc2026-04-30Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEGland Pharma Limitedd670bd26-8a44-44be-90e1-107d4c3802332026-04-28Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
glycopyrrolateGLYCOPYRROLATEAmneal Pharmaceuticals LLC741355f5-b695-41bb-a065-4abc687312b22026-04-28Warnings, Adverse reactionsName fallback
brand name: glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATESagent Pharmaceuticals55930f87-8964-43b1-b790-c1e6dd2602d22026-04-20Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack21c7d201-c0b8-4f16-be4a-681d0b22791e2026-04-03Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATESandoz Inccb1ae370-ec4f-4114-9860-8f736f72b5452026-04-01Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.a338ef22-c243-4075-b02d-bcd5b590104a2026-03-26Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.fafea739-87d0-4421-833f-eb066791504c2026-03-26Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.