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Diphenoxylate Hydrochloride and Atropine Sulfate - 0054-3194-46 - (Diphenoxylate Hydrochloride and Atropine Sulfate)

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Drug Information of Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 0054-3194
Proprietary Name: Diphenoxylate Hydrochloride and Atropine Sulfate
Non Proprietary Name: Diphenoxylate Hydrochloride and Atropine Sulfate
Active Ingredient(s): .025; 2.5    mg/5mL; mg/5mL & nbsp;   Diphenoxylate Hydrochloride and Atropine Sulfate
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 0054-3194
Labeler Name: Roxane Laboratories, Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA087708
Marketing Category: ANDA
Start Marketing Date: 19820503

Package Information of Diphenoxylate Hydrochloride and Atropine Sulfate

Package NDC: 0054-3194-46
Package Description: 1 BOTTLE, DROPPER in 1 CARTON (0054-3194-46) > 60 mL in 1 BOTTLE, DROPPER

NDC Information of Diphenoxylate Hydrochloride and Atropine Sulfate

NDC Code 0054-3194-46
Proprietary Name Diphenoxylate Hydrochloride and Atropine Sulfate
Package Description 1 BOTTLE, DROPPER in 1 CARTON (0054-3194-46) > 60 mL in 1 BOTTLE, DROPPER
Product NDC 0054-3194
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 19820503
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc
Substance Name ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Strength Number .025; 2.5
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Antidiarrheal [EPC]

Complete Information of Diphenoxylate Hydrochloride and Atropine Sulfate


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