FDA Orange Book · active-ingredient family
Secobarbital sodium
Secobarbital sodium: 1 brand, 22 generics; first approved Oct 03, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
22
Listed patents
0
Presentations
27
Brand (NDA) products
Originator applications
- LILLYNDA 007392-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (22)
Abbreviated applications
- VALEANT PHARMS NORTHANDA 08610119832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued - 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMANABOLICANDA 084422-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMBARRANDA 084225-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMEVERYLIFEANDA 085895-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMHALSEYANDA 084676-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMIVAX PHARMSANDA 085869-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMKV PHARMANDA 085285-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMLANNETTANDA 085909-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMLANNETTANDA 085903-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMPARKE DAVISANDA 084762-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMPERRIGOANDA 084561-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMPUREPAC PHARMANDA 085867-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMVALEANT PHARM INTLANDA 085477-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMVITARINEANDA 085898-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMVITARINEANDA 086273-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMWATSON LABSANDA 085792-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMWEST WARDANDA 084926-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMWHITEWORTH TOWN PLSNANDA 085798-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMWYETH AYERSTANDA 086390-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - - SECOBARBITAL SODIUMELKINS SINNANDA 083281-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued - - SECOBARBITAL SODIUMWYETH AYERSTANDA 083262-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - LILLYANDA 086530-4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG SUPPOSITORY RECTAL Discontinued - 60MG SUPPOSITORY RECTAL Discontinued - 120MG SUPPOSITORY RECTAL Discontinued - 200MG SUPPOSITORY RECTAL 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
43 yr 9 mo ago
Most recent approval
43 yr 9 mo ago
All 23 applications were approved in 1983.
Brand (NDA) 14%
Generic (ANDA) 2296%
Secobarbital sodium: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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