Details for New Drug Application (NDA): 210819
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NDA 210819 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by Hikma, Able, Ani Pharms, Ascot, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Parke Davis, Pharmobedient, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma Intl, Sun Pharm Industries, Unichem, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, and Winder Labs Llc, and is included in twenty-eight NDAs. It is available from eighteen suppliers. Additional details are available on the DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE profile page.
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 suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
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 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: | Unichem |
| 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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