← FDA DRUG APPROVALS

FDA NDA · NDA019593

ZANTAC IN PLASTIC CONTAINER

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA019593
TYPE
NDA
ORIGINAL APPROVAL
1986-12-17
LATEST ACTION
2009-09-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZANTAC IN PLASTIC CONTAINERDiscontinued
RANITIDINE HYDROCHLORIDE EQ 50MG BASE/100ML · INJECTABLE · INJECTION
ZANTAC IN PLASTIC CONTAINERDiscontinued
RANITIDINE HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION

Approval history

2009-09-04Labeling · Supplement 42 · standard — Label ↗AP
2009-02-17Labeling · Supplement 39 · standard — Label ↗AP
2006-07-12Labeling · Supplement 38 · standard — Letter ↗AP
2002-01-15Manufacturing (CMC) · Supplement 34 · standardAP
2002-01-07Labeling · Supplement 33 · standard — Letter ↗AP
2001-12-13Manufacturing (CMC) · Supplement 35 · standardAP
2001-05-09Labeling · Supplement 32 · standardAP
1999-10-29Labeling · Supplement 31 · standardAP
1999-10-29Labeling · Supplement 28 · standard — Label ↗AP
1999-10-22Labeling · Supplement 30 · standardAP
1999-10-22Labeling · Supplement 29 · standardAP
1994-11-03Labeling · Supplement 26 · standardAP
1994-08-10Labeling · Supplement 25 · standardAP
1993-04-05Labeling · Supplement 21AP
1992-08-12Manufacturing (CMC) · Supplement 23 · standardAP
1992-07-22Manufacturing (CMC) · Supplement 20 · standardAP
1992-02-18Manufacturing (CMC) · Supplement 19 · standardAP
1991-11-25Labeling · Supplement 12AP
1991-09-05Labeling · Supplement 18AP
1991-01-17Manufacturing (CMC) · Supplement 15 · standardAP
1990-12-20Manufacturing (CMC) · Supplement 17 · standardAP
1990-12-12Manufacturing (CMC) · Supplement 14 · standardAP
1990-11-21Labeling · Supplement 16AP
1990-08-13Labeling · Supplement 11AP
1990-07-16Labeling · Supplement 13AP
1989-08-08Manufacturing (CMC) · Supplement 8 · standardAP
1989-05-18Labeling · Supplement 10AP
1989-03-17Labeling · Supplement 5AP
1988-05-20Labeling · Supplement 7AP
1988-05-20Labeling · Supplement 6AP
1988-01-04Labeling · Supplement 4AP
1987-05-18Manufacturing (CMC) · Supplement 2 · standardAP
1986-12-17Type 3 - New Dosage Form · Original · standardAP
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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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