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PILOCARPINE HYDROCHLORIDE

ANDA

PILOCARPINE HYDROCHLORIDE | A204398 | RISING PHARMA HOLDINGS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ISOPTO CARPINE(TE code: AT)

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

1 letter from Drugs@FDA

Date	Submission	Document
Sep 29, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — 1%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Sep 27, 2017

No patent or exclusivity listings for this strength.

#002 — 2%

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Sep 27, 2017

#003 — 4%

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Sep 27, 2017