Orange Book product · Generic (ANDA)
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
DIPHENHYDRAMINE CITRATE; IBUPROFEN
At a glance
Dec 22, 2008
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2008
17 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Strength
38MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 079113
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIPHENHYDRAMINE CITRATE; IBUPROFEN
- 2005ADVIL PMBrand (NDA)
NDA 021394 · HALEON US HOLDINGS
- 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
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.
