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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204398
Company: RISING

Products on ANDA 204398

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION;OPHTHALMIC	Prescription	AT	No	No
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION;OPHTHALMIC	Prescription	AT	No	No
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204398

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204398Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 204398

PILOCARPINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOPTO CARPINE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION;OPHTHALMIC	Prescription	Yes	AT	200890	SANDOZ
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION;OPHTHALMIC	Prescription	No	AT	214193	AMNEAL
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION;OPHTHALMIC	Prescription	No	AT	204398	RISING
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION;OPHTHALMIC	Prescription	No	AT	210384	SOMERSET THERAPS LLC

SOLUTION;OPHTHALMIC; 2%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOPTO CARPINE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION;OPHTHALMIC	Prescription	Yes	AT	200890	SANDOZ
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION;OPHTHALMIC	Prescription	No	AT	214193	AMNEAL
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION;OPHTHALMIC	Prescription	No	AT	204398	RISING
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION;OPHTHALMIC	Prescription	No	AT	210384	SOMERSET THERAPS LLC

SOLUTION;OPHTHALMIC; 4%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOPTO CARPINE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION;OPHTHALMIC	Prescription	Yes	AT	200890	SANDOZ
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION;OPHTHALMIC	Prescription	No	AT	214193	AMNEAL
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION;OPHTHALMIC	Prescription	No	AT	204398	RISING
PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION;OPHTHALMIC	Prescription	No	AT	210384	SOMERSET THERAPS LLC

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