Details for New Drug Application (NDA): 210257
✉ Email this page to a colleague
NDA 210257 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 210257
| Tradename: | DICYCLOMINE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
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 | ||||
Complete Access Available with Subscription
