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FDA Orange Book · active-ingredient family

Beclomethasone dipropionate monohydrate

Beclomethasone dipropionate monohydrate: 3 brands, 0 generics; first approved Jul 27, 1987.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity — brand product(s) only.

Brands (NDA)
3
Generics (ANDA)
0
Listed patents
0
Presentations
3
Originator applications

Brand (NDA) products

BECONASE AQRLD
NDA 0193891987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.042MG DIPROP/SPRAYSPRAY, METEREDNASALDiscontinued—
VANCENASE AQ
NDA 0204691996
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.084MG DIPROP/SPRAYSPRAY, METEREDNASALDiscontinued—
VANCENASE AQ
NDA 0195891987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 0.042MG DIPROP/SPRAYSPRAY, METEREDNASALDiscontinued—
Orange Book patent file

Listed patents

Listed patents

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.

FDA approval span

Approval history

First approval
Jul 27, 1987
39 yr 6 mo ago
Most recent approval
Jun 26, 1996
30 yr 6 mo ago

Approvals span 1987–1996 across 3 FDA applications.

Brand (NDA) 3100%
Generic (ANDA) 00%

Beclomethasone dipropionate monohydrate — 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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