Details for New Drug Application (NDA): 218018
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The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 218018
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Annora Pharma |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 218018
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 218018
Suppliers and Packaging for NDA: 218018
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 218018 | ANDA | Camber Pharmaceuticals, Inc. | 31722-052 | 31722-052-01 | 100 CAPSULE in 1 BOTTLE (31722-052-01) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 218018 | ANDA | Camber Pharmaceuticals, Inc. | 31722-052 | 31722-052-05 | 500 CAPSULE in 1 BOTTLE (31722-052-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 1, 2024 | TE: | AB | RLD: | No |
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