FDA Orange Book · active-ingredient family
Demeclocycline hydrochloride
Demeclocycline hydrochloride: 3 brands, 5 generics; first approved Mar 22, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
5
Listed patents
0
Presentations
15
Brand (NDA) products
Originator applications
- LEDERLENDA 050262—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Discontinued — - LEDERLENDA 050257—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/5ML SYRUP ORAL Discontinued — - COREPHARMANDA 050261—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- DEMECLOCYCLINE HYDROCHLORIDEEPIC PHARMA LLCANDA 06544720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - DEMECLOCYCLINE HYDROCHLORIDEEPIC PHARMA LLCANDA 06538920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - DEMECLOCYCLINE HYDROCHLORIDEAMNEAL PHARMANDA 06542520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - DEMECLOCYCLINE HYDROCHLORIDEBARRANDA 06517120042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - DEMECLOCYCLINE HYDROCHLORIDEIMPAX LABSANDA 06509420042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 300MG TABLET 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
22 yr 9 mo ago
Most recent approval
11 yr 2 mo ago
Approvals span 2004–2015 across 8 FDA applications.
Brand (NDA) 338%
Generic (ANDA) 563%
Demeclocycline 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.
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.
