Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219136
Company: MANKIND PHARMA

Products on ANDA 219136

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219136

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALCAINE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	080027	ALCON LABS INC
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040074	BAUSCH AND LOMB INC
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	219136	MANKIND PHARMA
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	219294	MICRO LABS
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040277	RISING
PROPARACAINE HYDROCHLORIDE	PROPARACAINE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215816	SOMERSET THERAPS LLC