Details for New Drug Application (NDA): 212286
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The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 212286
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212286
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 212286
Suppliers and Packaging for NDA: 212286
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | SYRUP;ORAL | 212286 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0622 | 0054-0622-63 | 473 mL in 1 BOTTLE (0054-0622-63) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | SYRUP;ORAL | 212286 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0623 | 17856-0623-1 | 72 CUP, UNIT-DOSE in 1 PACKAGE (17856-0623-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0623-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML | ||||
Approval Date: | May 22, 2020 | TE: | AA | RLD: | No |
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