Details for New Drug Application (NDA): 040319
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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 040319
Tradename: | DICYCLOMINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Usa |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 040319
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 040319
Suppliers and Packaging for NDA: 040319
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 040319 | ANDA | Aurobindo Pharma Limited | 59651-719 | 59651-719-01 | 100 CAPSULE in 1 BOTTLE (59651-719-01) |
DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 040319 | ANDA | Aurobindo Pharma Limited | 59651-719 | 59651-719-99 | 1000 CAPSULE in 1 BOTTLE (59651-719-99) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 7, 1999 | TE: | AB | RLD: | No |
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