FDA Orange Book · active-ingredient family
Chlordiazepoxide hydrochloride
Chlordiazepoxide hydrochloride: 2 brands, 77 generics; first approved Jan 07, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 77 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
77
Listed patents
0
Presentations
83
Brand (NDA) products
Originator applications
- LIBRIUMRLDVALEANT PHARM INTLNDA 012249—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — 5MG CAPSULE ORAL Discontinued — 25MG CAPSULE ORAL Discontinued — - BAUSCHNDA 012301—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/AMP INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (77)
Abbreviated applications
- CHLORDIAZEPOXIDE HYDROCHLORIDEPIONEER PHARMSANDA 0895331988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPIONEER PHARMSANDA 0895581988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDESUPERPHARMANDA 0889871985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDESUPERPHARMANDA 0889861985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDESUPERPHARMANDA 0889881985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDETEVAANDA 0887051985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDETEVAANDA 0887061985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDETEVAANDA 0887071985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEVANGARDANDA 0881291983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEVANGARDANDA 0880101983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEVANGARDANDA 0881301983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEASCOTANDA 0875251982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEASCOTANDA 0875241982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEASCOTANDA 0875121982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - ABBOTTANDA 085447—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — 25MG CAPSULE ORAL Discontinued — - ABBOTTANDA 085517—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - ABBOTTANDA 085518—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - ABBOTTANDA 085513—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - RACHELLEANDA 085086—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - RACHELLEANDA 084639—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - RACHELLEANDA 085087—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDERLDBARRANDA 084768—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB - CHLORDIAZEPOXIDE HYDROCHLORIDERLDBARRANDA 083116—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - CHLORDIAZEPOXIDE HYDROCHLORIDERLDRSBARRANDA 084769—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - CHLORDIAZEPOXIDE HYDROCHLORIDECHARTWELL RXANDA 084678—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB - CHLORDIAZEPOXIDE HYDROCHLORIDECHARTWELL RXANDA 084041—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - CHLORDIAZEPOXIDE HYDROCHLORIDECHARTWELL RXANDA 084679—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - CHLORDIAZEPOXIDE HYDROCHLORIDEFERRANTEANDA 085118—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEFERRANTEANDA 085119—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEFERRANTEANDA 085120—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEHALSEYANDA 085340—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEHALSEYANDA 085339—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEHALSEYANDA 084685—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEIMPAX LABSANDA 086213—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEIMPAX LABSANDA 085113—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEIMPAX LABSANDA 086212—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083741—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083742—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083570—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDELEDERLEANDA 086892—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDELEDERLEANDA 087234—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDELEDERLEANDA 086876—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDELEDERLEANDA 087037—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDELEDERLEANDA 086893—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDELEDERLEANDA 087231—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEMAST MMANDA 086217—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEMYLANANDA 084886—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEMYLANANDA 084601—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEMYLANANDA 084887—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPARKE DAVISANDA 085163—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPARKE DAVISANDA 084598—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPARKE DAVISANDA 085164—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPUREPAC PHARMANDA 085155—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPUREPAC PHARMANDA 084939—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEPUREPAC PHARMANDA 085144—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEROXANEANDA 084706—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEROXANEANDA 084700—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEROXANEANDA 084705—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDETEVAANDA 086494—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEUPSHER SMITH LABSANDA 084919—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDERLDUPSHER SMITH LABSANDA 084920—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEUPSHER SMITH LABSANDA 084823—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEUSL PHARMAANDA 084644—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEUSL PHARMAANDA 084623—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEUSL PHARMAANDA 084645—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEWATSON LABSANDA 086383—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEWATSON LABSANDA 086294—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEWATSON LABSANDA 086382—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEWEST WARDANDA 085014—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEWEST WARDANDA 085000—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - CHLORDIAZEPOXIDE HYDROCHLORIDEWEST WARDANDA 085294—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - LIBRIUMRLDBAUSCHANDA 085461—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB - LIBRIUMRLDBAUSCHANDA 085472—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB - LIBRIUMRLDBAUSCHANDA 085475—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - ALRAANDA 085107—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued — - ALRAANDA 085009—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - ALRAANDA 085108—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
38 yr 8 mo ago
Approvals span 1982–1988 across 79 FDA applications.
Brand (NDA) 23%
Generic (ANDA) 7797%
Chlordiazepoxide hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
