Details for New Drug Application (NDA): 214065
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NDA 214065 describes CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE profile page.
The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is chlordiazepoxide hydrochloride; clidinium bromide. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.
The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is chlordiazepoxide hydrochloride; clidinium bromide. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.
Summary for 214065
| Tradename: | CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | chlordiazepoxide hydrochloride; clidinium bromide |
| Patents: | 0 |
Pharmacology for NDA: 214065
| Mechanism of Action | Cholinergic Antagonists |
| Physiological Effect | Decreased Parasympathetic Acetylcholine Activity Digestive/GI System Activity Alteration GI Motility Alteration |
Suppliers and Packaging for NDA: 214065
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 214065 | ANDA | American Health Packaging | 60687-639 | 60687-639-94 | 20 BLISTER PACK in 1 CARTON (60687-639-94) / 1 CAPSULE in 1 BLISTER PACK (60687-639-11) |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 214065 | ANDA | Bryant Ranch Prepack | 63629-8859 | 63629-8859-1 | 100 CAPSULE in 1 BOTTLE (63629-8859-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG;2.5MG | ||||
| Approval Date: | Apr 26, 2021 | TE: | AB | RLD: | No | ||||
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