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ISOPTO CARPINE

NDA

PILOCARPINE HYDROCHLORIDE | N200890 | SANDOZ INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

ANIDRO DO BRASIL EXTRACOES SAPILOCARPINE HYDROCHLORIDE USP

DMF 100251992

SPERA NEXUS INCPILOCARPINE HYDROCHLORIDE

DMF 123881997

SOURCETECH QUIMICA LTDAPILOCARPINE HYDROCHLORIDE

DMF 168732003

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDPILOCARPINE HYDROCHLORIDE

DMF 389012023

LINNEA PHYTOCHEMICALSInactivePILOCARPINE HYDROCHLORIDE

DMF 75361988

ANIDRO DO BRASIL EXTRACOES SAInactivePILOCARPINE HYDROCHLORIDE

DMF 84531990

BOEHRINGER INGELHEIM PHARMA KGInactivePILOCARPINE HYDROCHLORIDE

DMF 93321991

PVP SOCIEDADE ANONIMAInactivePILOCARPINE HYDROCHLORIDE

DMF 108611994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 12, 2010	SUPPL -1	View Letter (PDF)
Jun 29, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 22, 2010

No patent or exclusivity listings for this strength.

#002 — 2%

RLDAT

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 22, 2010

#003 — 4%

RLDAT

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 22, 2010