Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 216496

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216496

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

Therapeutic Equivalents for ANDA 216496

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	215183	CAPLIN
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	218129	GLAND PHARMA LTD
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