Details for New Drug Application (NDA): 210257
NDA 210257 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Hikma, Lannett, Pioneer Pharms, Prinston Inc, Rising, Rubicon Research, Solgen, Sun Pharm Industries, Twi Pharms, Watson Labs, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Nexus, Quagen, Renew Pharms, Slate Run Pharma, Somerset Theraps Llc, Alpharma Us Pharms, Novitium Pharma, Ph Health, and Bionpharma, and is included in forty-three NDAs. It is available from forty-three suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.
The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There is one drug master file entry for this compound. Forty-three 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 is one drug master file entry for this compound. Forty-three 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 | ||||
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