← FDA Drug Approvals (Drugs@FDA)
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ONESOURCE SPECIALTY · Approved 2012-03-05
Drug application
- FDA Application #
ANDA200888- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- Generic name
- IBUPROFEN, DIPHENHYDRAMINE HCL
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- ONESOURCE SPECIALTY
- Manufacturer
- TOP CARE (Topco Associates LLC)
- First approval
- 2012-03-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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