Details for New Drug Application (NDA): 217054
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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 217054
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Twi Pharms |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217054
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 217054
Suppliers and Packaging for NDA: 217054
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 217054 | ANDA | TWi Pharmaceuticals, Inc. | 24979-201 | 24979-201-01 | 100 CAPSULE in 1 BOTTLE (24979-201-01) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 217054 | ANDA | TWi Pharmaceuticals, Inc. | 24979-201 | 24979-201-03 | 1000 CAPSULE in 1 BOTTLE (24979-201-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 27, 2022 | TE: | AB | RLD: | No |
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