pantoprazole 40 MG Delayed Release Oral Tablet
1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). ( 1.1 ) Maintenance of Healing of Erosive Esophagitis. ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome. ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
Amneal Pharmaceuticals of New York, LLC
OVAL YELLOW A37
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pantoprazole 40 MG Delayed Release Oral Tablet
Amneal Pharmaceuticals of New York, LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
PANTOPRAZOLE sodium delayed-release tablets USP, 20 mg are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-636-03 Bottles of 90: NDC 65162-636-09
PANTOPRAZOLE sodium delayed-release tablets USP, 40 mg are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A37” with black ink on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-637-03 Bottles of 90: NDC 65162-637-09 Bottles of 500: NDC 65162-637-50 Bottles of 1000: NDC 65162-637-11 Storage Store
PANTOPRAZOLE sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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