Orange Book product · Brand (NDA)
ADVIL PM
DIPHENHYDRAMINE CITRATE; IBUPROFEN
At a glance
Dec 21, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2005
20 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Strength
38MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021394
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024IBUPROFEN AND DIPHENHYDRAMINE CITRATEGeneric (ANDA)
ANDA 211404 · PLD ACQUISITIONS LLC
- 2022IBUPROFEN AND DIPHENHYDRAMINE CITRATEGeneric (ANDA)
ANDA 216204 · AUROBINDO PHARMA
- 2009IBUPROFEN AND DIPHENHYDRAMINE CITRATEGeneric (ANDA)
ANDA 090619 · DR REDDYS LABS LTD
- 2008IBUPROFEN AND DIPHENHYDRAMINE CITRATEGeneric (ANDA)
ANDA 079113 · PERRIGO R AND D
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.
