Details for New Drug Application (NDA): 207076
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NDA 207076 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-four 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-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. Forty-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 207076
| Tradename: | DICYCLOMINE HYDROCHLORIDE |
| Applicant: | Slate Run Pharma |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207076
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 207076
Suppliers and Packaging for NDA: 207076
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 207076 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-147 | 70436-147-80 | 2 mL in 1 VIAL (70436-147-80) |
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 207076 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-147 | 70436-147-81 | 5 VIAL, SINGLE-DOSE in 1 BOX (70436-147-81) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Nov 2, 2018 | TE: | AP | RLD: | No | ||||
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