Details for New Drug Application (NDA): 012462
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NDA 012462 describes LOMOTIL, which is a drug marketed by Gd Searle Llc and Pfizer and is included in two NDAs. It is available from three suppliers. Additional details are available on the LOMOTIL profile page.
The generic ingredient in LOMOTIL 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 LOMOTIL 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 012462
| Tradename: | LOMOTIL |
| Applicant: | Pfizer |
| Ingredient: | atropine sulfate; diphenoxylate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 012462
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 012462
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOMOTIL | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 012462 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-0061 | 0025-0061-31 | 100 TABLET in 1 BOTTLE (0025-0061-31) |
| LOMOTIL | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 012462 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-083 | 43353-083-30 | 30 TABLET in 1 BOTTLE (43353-083-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.025MG;2.5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
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