Details for New Drug Application (NDA): 208353
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NDA 208353 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, Somerset Theraps Llc, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, Rising, and Rubicon, and is included in forty NDAs. It is available from fifty-two 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-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 are four drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 208353
| Tradename: | DICYCLOMINE HYDROCHLORIDE |
| Applicant: | Am Regent |
| Ingredient: | dicyclomine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208353
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 208353
Suppliers and Packaging for NDA: 208353
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 208353 | ANDA | American Regent, Inc. | 0517-1980 | 0517-1980-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) |
| DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 208353 | ANDA | American Regent, Inc. | 0517-1980 | 0517-1980-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Feb 17, 2017 | TE: | AP | RLD: | No | ||||
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