Details for New Drug Application (NDA): 217531
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The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 217531
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Prinston Inc |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217531
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 217531
Suppliers and Packaging for NDA: 217531
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 217531 | ANDA | Solco Healthcare US,LLC | 43547-634 | 43547-634-10 | 100 CAPSULE in 1 BOTTLE (43547-634-10) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 217531 | ANDA | Solco Healthcare US,LLC | 43547-634 | 43547-634-11 | 1000 CAPSULE in 1 BOTTLE (43547-634-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 30, 2023 | TE: | AB | RLD: | No |
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