Details for New Drug Application (NDA): 084285
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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 084285
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Lannett |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 084285
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 084285
Suppliers and Packaging for NDA: 084285
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 084285 | ANDA | Lannett Company, Inc. | 0527-0586 | 0527-0586-01 | 100 CAPSULE in 1 BOTTLE (0527-0586-01) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 084285 | ANDA | Lannett Company, Inc. | 0527-0586 | 0527-0586-05 | 500 CAPSULE in 1 BOTTLE (0527-0586-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
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