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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200890
Company: SANDOZ

Summary Review

Products on NDA 200890

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOPTO CARPINE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION;OPHTHALMIC	Prescription	AT	Yes	Yes
ISOPTO CARPINE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION;OPHTHALMIC	Prescription	AT	Yes	Yes
ISOPTO CARPINE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200890

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2010	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200890s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200890_carpine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200890s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/27/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/07/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/08/2010	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200890s001ltr.pdf

Labels for NDA 200890

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2010	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s001lbl.pdf
06/22/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200890s000lbl.pdf

Therapeutic Equivalents for NDA 200890

ISOPTO CARPINE

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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