APPLICATION
ANDA076963
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-22
LATEST ACTION
2020-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PILOCARPINE HYDROCHLORIDEPrescription
PILOCARPINE HYDROCHLORIDE 5MG · TABLET · ORAL
PILOCARPINE HYDROCHLORIDEPrescription
PILOCARPINE HYDROCHLORIDE 7.5MG · TABLET · ORAL
Approval history
2020-08-26Labeling · Supplement 9 · standardAP
2008-01-16Labeling · Supplement 5AP
2007-02-27Labeling · Supplement 1AP
2007-02-27Manufacturing (CMC) · Supplement 2AP
2004-12-22OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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