← FDA DRUG APPROVALS

FDA NDA · NDA017831

DIDRONEL

Sponsor: APIL

APPLICATION
NDA017831
TYPE
NDA
ORIGINAL APPROVAL
1977-09-01
LATEST ACTION
2015-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DIDRONEL · ReferenceDiscontinued
ETIDRONATE DISODIUM 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DIDRONEL · ReferenceDiscontinued
ETIDRONATE DISODIUM 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-04-08Labeling · Supplement 58 · standard — Label ↗AP
2015-03-18Labeling · Supplement 57 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 56 · standard — Letter ↗AP
2009-12-31Labeling · Supplement 55 · standard — Letter ↗AP
2006-01-09Labeling · Supplement 54 · standard — Label ↗AP
2004-02-25Labeling · Supplement 53 · standard — Letter ↗AP
2002-03-15Labeling · Supplement 52 · standard — Letter ↗AP
1997-06-18Labeling · Supplement 51 · standardAP
1997-06-16Labeling · Supplement 50 · standardAP
1996-10-04Labeling · Supplement 49 · standardAP
1996-02-29Labeling · Supplement 48 · standardAP
1996-02-27Labeling · Supplement 46 · standardAP
1994-05-05Labeling · Supplement 44 · standardAP
1993-09-28Manufacturing (CMC) · Supplement 43 · priorityAP
1993-06-07Labeling · Supplement 42 · standardAP
1989-07-05Labeling · Supplement 38AP
1988-09-23Labeling · Supplement 36AP
1988-08-02Labeling · Supplement 37AP
1988-03-01Labeling · Supplement 35AP
1986-07-10Manufacturing (CMC) · Supplement 34 · priorityAP
1986-07-10Manufacturing (CMC) · Supplement 32 · priorityAP
1986-03-24Labeling · Supplement 33AP
1986-01-07Manufacturing (CMC) · Supplement 31 · priorityAP
1986-01-07Manufacturing (CMC) · Supplement 30 · priorityAP
1984-07-06Manufacturing (CMC) · Supplement 28 · priorityAP
1984-07-06Labeling · Supplement 29AP
1983-01-11Manufacturing (CMC) · Supplement 19 · priorityAP
1983-01-11Labeling · Supplement 18AP
1983-01-08Manufacturing (CMC) · Supplement 21 · priorityAP
1982-09-08Labeling · Supplement 15AP
1982-08-25Manufacturing (CMC) · Supplement 17 · priorityAP
1981-08-04Labeling · Supplement 13AP
1980-10-01Manufacturing (CMC) · Supplement 12 · priorityAP
1980-08-25Efficacy · Supplement 9AP
1980-05-14Labeling · Supplement 11AP
1979-12-13Manufacturing (CMC) · Supplement 10 · priorityAP
1979-01-23Manufacturing (CMC) · Supplement 7 · priorityAP
1979-01-23Manufacturing (CMC) · Supplement 5 · priorityAP
1979-01-23Manufacturing (CMC) · Supplement 6 · priorityAP
1979-01-23Efficacy · Supplement 4AP
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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