Details for New Drug Application (NDA): 212286
✉ Email this page to a colleague
NDA 212286 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Sun Pharm Industries, Twi Pharms, Watson Labs, West Ward, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Hikma, Nexus, Praxgen Pharms, Renew Pharms, Slate Run Pharma, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in thirty-seven NDAs. It is available from fifty-three suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.
The generic ingredient in DICYCLOMINE HYDROCHLORIDE 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.
The generic ingredient in DICYCLOMINE HYDROCHLORIDE 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 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 | ||||
Complete Access Available with Subscription
