Details for New Drug Application (NDA): 210257
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NDA 210257 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by 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, Generics, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in thirty-five NDAs. It is available from fifty-one 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-two 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-two suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 210257
| Tradename: | DICYCLOMINE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210257
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 210257
Suppliers and Packaging for NDA: 210257
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 210257 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1559 | 51662-1559-3 | 5 POUCH in 1 CASE (51662-1559-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1559-2) / 2 mL in 1 VIAL, SINGLE-DOSE |
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 210257 | ANDA | Fresenius Kabi USA, LLC | 63323-842 | 63323-842-02 | 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jan 25, 2019 | TE: | AP | RLD: | No | ||||
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