Orange Book product · Generic (ANDA)
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
DIPHENHYDRAMINE CITRATE; IBUPROFEN
At a glance
May 31, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 2022
4 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Strength
38MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 216204
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
- 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.
