Details for New Drug Application (NDA): 210819
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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 210819
Tradename: | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
Applicant: | Bayshore Pharms Llc |
Ingredient: | atropine sulfate; diphenoxylate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210819
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 210819
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 | 210819 | ANDA | Bayshore Pharmaceuticals, LLC | 76385-107 | 76385-107-01 | 100 TABLET in 1 BOTTLE (76385-107-01) |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 210819 | ANDA | Bayshore Pharmaceuticals, LLC | 76385-107 | 76385-107-10 | 1000 TABLET in 1 BOTTLE (76385-107-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.025MG;2.5MG | ||||
Approval Date: | Nov 13, 2018 | TE: | AA | RLD: | No |
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