Details for New Drug Application (NDA): 012750
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The generic ingredient in LIBRAX 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 012750
Tradename: | LIBRAX |
Applicant: | Bausch |
Ingredient: | chlordiazepoxide hydrochloride; clidinium bromide |
Patents: | 0 |
Pharmacology for NDA: 012750
Mechanism of Action | Cholinergic Antagonists |
Physiological Effect | Decreased Parasympathetic Acetylcholine Activity Digestive/GI System Activity Alteration GI Motility Alteration |
Suppliers and Packaging for NDA: 012750
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIBRAX | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 012750 | NDA | Bausch Health US, LLC | 0187-4100 | 0187-4100-10 | 100 CAPSULE in 1 BOTTLE (0187-4100-10) |
LIBRAX | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 012750 | NDA AUTHORIZED GENERIC | Cameron Pharmaceuticals, LLC | 42494-409 | 42494-409-01 | 100 CAPSULE in 1 BOTTLE (42494-409-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG;2.5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 012750
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | LIBRAX | chlordiazepoxide hydrochloride; clidinium bromide | CAPSULE;ORAL | 012750-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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