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IBUPROFEN AND DIPHENHYDRAMINE CITRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2022-05-31

Drug application

FDA Application #
ANDA216204
Application type
Abbreviated New Drug Application (Generic)
Brand name
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Generic name
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Active ingredients
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Dosage form
TABLET
Route
ORAL
Marketing status
Over-the-counter
Sponsor
AUROBINDO PHARMA
Manufacturer
KROGER COMPANY
First approval
2022-05-31

Source

Authoritative
Drugs@FDA application overview
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