Details for New Drug Application (NDA): 087708
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The generic ingredient in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for 087708
Tradename: | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
Applicant: | Hikma |
Ingredient: | atropine sulfate; diphenoxylate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 087708
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 087708
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | SOLUTION;ORAL | 087708 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3194 | 0054-3194-46 | 1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.025MG/5ML;2.5MG/5ML | ||||
Approval Date: | May 3, 1982 | TE: | RLD: | No |
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