← FDA Drug Approvals (Drugs@FDA)
PHENYLEPHRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2024-05-23
Drug application
- FDA Application #
ANDA215183
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PHENYLEPHRINE HYDROCHLORIDE
- Generic name
- PHENYLEPHRINE HYDROCHLORIDE
- Active ingredients
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Sponsor
- CAPLIN
- Manufacturer
- Caplin Steriles Limited
- First approval
- 2024-05-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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