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- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Lifesciences Limited
Glycopyrrolate
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- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL NORTHSTAR RX LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Alembic Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Lifesciences Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Pharmaceuticals USA Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Cardinal Health 107, LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Meitheal Pharmaceuticals Inc.
- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL Henry Schein, Inc.
- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL Solco Healthcare US, LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Gland Pharma Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Alembic Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Lifesciences Limited
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Xiromed LLC
- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL HF Acquisition Co LLC, DBA HealthFirst
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Xiromed LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Pharmaceuticals USA Inc.
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL Henry Schein, Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Gland Pharma Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Alembic Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Lifesciences Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Pharmaceuticals USA Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Pharmaceuticals USA Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Fresenius Kabi USA, LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Meitheal Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Lifestar Pharma LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Fresenius Kabi USA, LLC
- PREVDUO GLYCOPYRROLATE .2 mg/mL PAR PHARMACEUTICAL, INC.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Gland Pharma Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Gland Pharma Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Sandoz Inc
- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL HF Acquisition Co LLC, DBA HealthFirst
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Cardinal Health 107, LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Apotex Corp.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Meitheal Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Xiromed LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Lifestar Pharma LLC
- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
-
Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
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- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Apotex Corp.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Apotex Corp.
- GLYCOPYRROLATE 1ML GLYCOPYRROLATE .2 mg/mL XIROMED LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Alembic Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL NORTHSTAR RX LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Zydus Lifesciences Limited
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Xiromed LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Lifestar Pharma LLC
-
Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Medical Purchasing Solutions, LLC
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Meitheal Pharmaceuticals Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Lifestar Pharma LLC
- GLYCOPYRROLATE GLYCOPYRROLATE .2 mg/mL Henry Schein, Inc.
- Glycopyrrolate GLYCOPYRROLATE .2 mg/mL Apotex Corp.
Summary of product characteristics
Effective Time
20221105
Version
2
Spl Product Data Elements
Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER
Application Number
ANDA214213
Brand Name
Glycopyrrolate
Generic Name
Glycopyrrolate
Product Ndc
70771-1616
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR,INTRAVENOUS
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1616-1 Glycopyrrolate Injection, USP 0.2 mg/mL NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 1 mL Single-Dose Vial Rx only NDC 70771-1616-7 Glycopyrrolate Injection, USP 0.2 mg/mL NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 25 x 1 mL Single-Dose Vials Rx only NDC 70771-1617-1 Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 2 mL Single-Dose Vial Rx only NDC 70771-1617-7 Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 25 x 2 mL Single-Dose Vials Rx only NDC 70771-1618-1 Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 5 mL Multiple-Dose Vial Rx only NDC 70771-1618-7 Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 25 x 5 mL Multiple-Dose Vials Rx only NDC 70771-1619-1 Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 20 mL Multiple-Dose Vial Rx only NDC 70771-1619-6 Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 10 x 20 mL Multiple-Dose Vials Rx only 1 mL vial carton of 25 of 1 mL vial 2 mL vial carton of 2 mL 25 vials 5 mL vial carton of 25 of 5 mL vial 20 mL vial carton of 10 - 20 mL vials
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