Details for New Drug Application (NDA): 211925
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The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.
Summary for 211925
Tradename: | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
Applicant: | Micro Labs |
Ingredient: | amitriptyline hydrochloride; chlordiazepoxide |
Patents: | 0 |
Suppliers and Packaging for NDA: 211925
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 211925 | ANDA | Micro Labs Limited | 42571-302 | 42571-302-01 | 100 TABLET in 1 BOTTLE (42571-302-01) |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; chlordiazepoxide | TABLET;ORAL | 211925 | ANDA | Micro Labs Limited | 42571-302 | 42571-302-05 | 500 TABLET in 1 BOTTLE (42571-302-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG BASE;5MG | ||||
Approval Date: | Feb 2, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE;10MG | ||||
Approval Date: | Feb 2, 2022 | TE: | AB | RLD: | No |
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