Details for New Drug Application (NDA): 217916
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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 217916
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Bionpharma |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 217916
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 217916
Suppliers and Packaging for NDA: 217916
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | TABLET;ORAL | 217916 | ANDA | Bionpharma Inc. | 69452-311 | 69452-311-20 | 100 TABLET in 1 BOTTLE, PLASTIC (69452-311-20) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | TABLET;ORAL | 217916 | ANDA | Bionpharma Inc. | 69452-311 | 69452-311-32 | 1000 TABLET in 1 BOTTLE, PLASTIC (69452-311-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Aug 4, 2023 | TE: | AB | RLD: | No |
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