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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216496
Company: MANKIND PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription AT No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/11/2023 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216496Orig1s000ltr.pdf

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; 10%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 207926 ALCON
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 216496 MANKIND PHARMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 203510 PARAGON BIOTECK
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