Details for New Drug Application (NDA): 085762
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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 085762
Tradename: | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
Applicant: | Mylan |
Ingredient: | atropine sulfate; diphenoxylate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 085762
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 085762
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 | 085762 | ANDA | Proficient Rx LP | 63187-254 | 63187-254-15 | 15 TABLET in 1 BOTTLE, PLASTIC (63187-254-15) |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085762 | ANDA | Proficient Rx LP | 63187-254 | 63187-254-20 | 20 TABLET in 1 BOTTLE, PLASTIC (63187-254-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.025MG;2.5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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