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List of Drug Master Files (DMF) of Pilocarpine HCl Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Anidro do Brasil Extracoes
Brazil
ANIDRO DO BRASIL EXTRACOES SA 10025 PILOCARPINE HYDROCHLORIDE USP 1992-12-28 Active II Complete 2017-03-17 2017-02-22
26/09/2024 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM PHARMA KG 9332 PILOCARPINE HYDROCHLORIDE 1991-09-05 Inactive II N/A