Details for New Drug Application (NDA): 217531
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NDA 217531 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Rising, 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, Somerset Theraps Llc, Alpharma Us Pharms, Novitium Pharma, Ph Health, Bionpharma, Hikma Pharms, and Rubicon Research, and is included in forty-two NDAs. It is available from forty-six 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. Forty-six 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. Forty-six suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 217531
| Tradename: | DICYCLOMINE HYDROCHLORIDE |
| Applicant: | Prinston Inc |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217531
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 217531
Suppliers and Packaging for NDA: 217531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 217531 | ANDA | Solco Healthcare US,LLC | 43547-634 | 43547-634-10 | 100 CAPSULE in 1 BOTTLE (43547-634-10) |
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | CAPSULE;ORAL | 217531 | ANDA | Solco Healthcare US,LLC | 43547-634 | 43547-634-11 | 1000 CAPSULE in 1 BOTTLE (43547-634-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 30, 2023 | TE: | AB | RLD: | No | ||||
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