Details for New Drug Application (NDA): 213335
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NDA 213335 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by Hikma, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, 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 nineteen 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-one 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-one suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for 213335
| Tradename: | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
| Applicant: | Specgx Llc |
| Ingredient: | atropine sulfate; diphenoxylate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213335
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 213335
| 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 | 213335 | ANDA | SpecGx LLC | 0406-1236 | 0406-1236-01 | 100 TABLET in 1 BOTTLE (0406-1236-01) |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 213335 | ANDA | SpecGx LLC | 0406-1236 | 0406-1236-10 | 1000 TABLET in 1 BOTTLE (0406-1236-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.025MG;2.5MG | ||||
| Approval Date: | Oct 6, 2020 | TE: | AA | RLD: | No | ||||
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