Details for New Drug Application (NDA): 210571
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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 210571
Tradename: | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
Applicant: | Upsher Smith Labs |
Ingredient: | atropine sulfate; diphenoxylate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210571
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 210571
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 210571 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-957 | 43063-957-04 | 4 TABLET in 1 BOTTLE, PLASTIC (43063-957-04) |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 210571 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-957 | 43063-957-10 | 10 TABLET in 1 BOTTLE, PLASTIC (43063-957-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.025MG;2.5MG | ||||
Approval Date: | Aug 31, 2018 | TE: | RLD: | No |
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