Details for New Drug Application (NDA): 216736
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The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 216736
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Rubicon |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216736
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 216736
Suppliers and Packaging for NDA: 216736
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | TABLET;ORAL | 216736 | ANDA | Northwind Pharmaceuticals, LLC | 51655-548 | 51655-548-26 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-548-26) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | TABLET;ORAL | 216736 | ANDA | Northwind Pharmaceuticals, LLC | 51655-548 | 51655-548-52 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-548-52) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 14, 2022 | TE: | AB | RLD: | No |
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