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PILOCARPINE HYDROCHLORIDE

ANDA

PILOCARPINE HYDROCHLORIDE | A217052 | FDC LTD

3 strengths0 unique patents0 unique exclusivities

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.

Products (3)

Sort:

#001 — 1%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 2, 2025

No patent or exclusivity listings for this strength.

#002 — 2%

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 2, 2025

#003 — 4%

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 2, 2025

Change History (6)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

FDC LTD's Pilocarpine Hydrochloride (NDA 217052, supplement 003) changed from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

FDC Ltd's pilocarpine hydrochloride (PILOCARPINE HYDROCHLORIDE) NDA 217052 therapeutic equivalence code changed from AT.

Old: AT

MODIFIEDtype7/1/2026

FDC LTD's pilocarpine hydrochloride (ANDA 217052) transitioned from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

FDC Ltd's pilocarpine hydrochloride oral solution (NDA 217052) therapeutic equivalence code changed from AT to a different rating.

Old: AT

MODIFIEDtype7/1/2026

FDC Ltd's Pilocarpine Hydrochloride (NDA 217052) transitioned from prescription to discontinued product status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

FDC Ltd's pilocarpine hydrochloride ophthalmic solution (NDA 217052) had its therapeutic equivalence code changed from AT, affecting generic substitutability determinations for this product.

Old: AT