Details for New Drug Application (NDA): 008370
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The generic ingredient in BENTYL PRESERVATIVE FREE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 008370
Tradename: | BENTYL PRESERVATIVE FREE |
Applicant: | Abbvie |
Ingredient: | dicyclomine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 008370
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 008370
Suppliers and Packaging for NDA: 008370
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENTYL | dicyclomine hydrochloride | INJECTABLE;INJECTION | 008370 | NDA | A-S Medication Solutions | 50090-4553 | 50090-4553-0 | 2 mL in 1 AMPULE (50090-4553-0) |
BENTYL | dicyclomine hydrochloride | INJECTABLE;INJECTION | 008370 | NDA | Allergan, Inc. | 58914-080 | 58914-080-52 | 5 AMPULE in 1 BOX (58914-080-52) / 2 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Oct 15, 1984 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Oct 15, 1984 | TE: | RLD: | Yes |
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