← FDA DRUG APPROVALS

FDA NDA · NDA050347

TROBICIN

Sponsor: PFIZER

APPLICATION
NDA050347
TYPE
NDA
ORIGINAL APPROVAL
1971-06-30
LATEST ACTION
2012-08-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TROBICINDiscontinued
SPECTINOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
TROBICINDiscontinued
SPECTINOMYCIN HYDROCHLORIDE EQ 4GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2012-08-15Labeling · Supplement 60 · standard — Label ↗AP
2011-11-15Labeling · Supplement 58 · standard — Label ↗AP
2004-08-19Labeling · Supplement 52 · standard — Letter ↗AP
2002-05-15Manufacturing (CMC) · Supplement 49AP
2001-09-21Manufacturing (CMC) · Supplement 48AP
2001-07-17Manufacturing (CMC) · Supplement 47AP
1996-08-01Manufacturing (CMC) · Supplement 45AP
1996-08-01Manufacturing (CMC) · Supplement 46AP
1995-09-27Labeling · Supplement 44AP
1991-08-26Manufacturing (CMC) · Supplement 8AP
1991-08-23Manufacturing (CMC) · Supplement 7AP
1990-03-22Manufacturing (CMC) · Supplement 6AP
1981-10-30Manufacturing (CMC) · Supplement 43AP
1980-05-08Labeling · Supplement 41AP
1979-09-10Manufacturing (CMC) · Supplement 38AP
1979-04-10Labeling · Supplement 35AP
1979-04-10Manufacturing (CMC) · Supplement 36AP
1979-03-09Labeling · Supplement 37AP
1978-07-13Manufacturing (CMC) · Supplement 34AP
1977-07-26Manufacturing (CMC) · Supplement 33AP
1976-11-04Manufacturing (CMC) · Supplement 32AP
1976-08-03Labeling · Supplement 31AP
1975-09-12Labeling · Supplement 30AP
1975-07-08Labeling · Supplement 28AP
1975-06-03Labeling · Supplement 29AP
1974-12-24Labeling · Supplement 26AP
1974-05-23Labeling · Supplement 25AP
1973-06-18Labeling · Supplement 24AP
1973-03-09Labeling · Supplement 23AP
1972-12-05Labeling · Supplement 22AP
1972-10-24Labeling · Supplement 21AP
1972-08-21Labeling · Supplement 20AP
1972-04-10Labeling · Supplement 19AP
1972-02-25Labeling · Supplement 18AP
1971-10-04Labeling · Supplement 17AP
1971-09-10Labeling · Supplement 16AP
1971-08-19Labeling · Supplement 15AP
1971-07-06Labeling · Supplement 14AP
1971-06-30UNKNOWN · Original · unknownAP
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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