Details for New Drug Application (NDA): 040465
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NDA 040465 describes DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE), which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) profile page.
The generic ingredient in DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) 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.
The generic ingredient in DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) 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 040465
| Tradename: | DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) |
| Applicant: | Hikma |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 040465
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 040465
Suppliers and Packaging for NDA: 040465
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) | dicyclomine hydrochloride | INJECTABLE;INJECTION | 040465 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6173 | 0641-6173-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jun 30, 2003 | TE: | AP | RLD: | No | ||||
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