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FDA NDA · NDA020237

SALAGEN

pilocarpine hydrochloride

Sponsor: ADVANZ PHARMA

APPLICATION
NDA020237
TYPE
NDA
ORIGINAL APPROVAL
1994-03-22
LATEST ACTION
2015-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SALAGEN · ReferencePrescription
PILOCARPINE HYDROCHLORIDE 5MG · TABLET · ORAL
SALAGEN · ReferencePrescription
PILOCARPINE HYDROCHLORIDE 7.5MG · TABLET · ORAL

Approval history

2015-09-10Manufacturing (CMC) · Supplement 21 · priorityAP
2013-04-26Manufacturing (CMC) · Supplement 20 · priorityAP
2003-04-18Manufacturing (CMC) · Supplement 12 · priority — Label ↗AP
2002-09-04Manufacturing (CMC) · Supplement 11 · priorityAP
2002-06-10Labeling · Supplement 9 · standard — Label ↗AP
2002-06-10Labeling · Supplement 8 · standard — Letter ↗AP
2000-02-04Manufacturing (CMC) · Supplement 10 · priorityAP
1998-02-11Efficacy · Supplement 7 · standard — Review ↗AP
1997-03-11Labeling · Supplement 6 · standardAP
1996-09-27Labeling · Supplement 5 · standardAP
1996-04-18Manufacturing (CMC) · Supplement 1 · priorityAP
1995-11-09Manufacturing (CMC) · Supplement 3 · priorityAP
1995-11-09Manufacturing (CMC) · Supplement 4 · priority — Letter ↗AP
1995-11-09Manufacturing (CMC) · Supplement 2 · priority — Letter ↗AP
1994-03-22Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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