APPLICATION
NDA017362
TYPE
NDA
ORIGINAL APPROVAL
1978-05-11
LATEST ACTION
2018-08-21
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROGESTERONE · ReferenceDiscontinued
PROGESTERONE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-08-12Manufacturing (CMC) · Supplement 96 · standardAP
2001-01-25Manufacturing (CMC) · Supplement 95 · standardAP
2000-03-27Labeling · Supplement 89 · standardAP
1999-01-13Manufacturing (CMC) · Supplement 92 · standardAP
1998-08-20Manufacturing (CMC) · Supplement 90 · standardAP
1998-02-19Manufacturing (CMC) · Supplement 88 · standardAP
1997-01-22Manufacturing (CMC) · Supplement 86 · standardAP
1993-04-06Labeling · Supplement 85 · standardAP
1991-12-03Labeling · Supplement 84AP
1991-05-29Labeling · Supplement 75AP
1991-05-29Labeling · Supplement 78AP
1991-05-29Labeling · Supplement 82AP
1991-05-29Labeling · Supplement 80AP
1991-04-08Manufacturing (CMC) · Supplement 81 · standardAP
1991-02-15Labeling · Supplement 83AP
1988-11-15Manufacturing (CMC) · Supplement 79 · standardAP
1986-05-12Labeling · Supplement 77AP
1981-03-02Labeling · Supplement 74AP
1980-12-15Labeling · Supplement 72AP
1980-08-26Labeling · Supplement 71AP
1980-07-18Labeling · Supplement 70AP
1980-06-11Labeling · Supplement 69AP
1980-04-15Labeling · Supplement 68AP
1980-03-28Labeling · Supplement 67AP
1980-02-15Labeling · Supplement 66AP
1980-02-12Labeling · Supplement 65AP
1980-02-06Labeling · Supplement 63AP
1980-02-06Labeling · Supplement 64AP
1980-01-22Labeling · Supplement 61AP
1979-12-14Labeling · Supplement 59AP
1979-12-14Labeling · Supplement 57AP
1979-12-12Labeling · Supplement 60AP
1979-12-10Labeling · Supplement 58AP
1979-11-29Labeling · Supplement 55AP
1979-11-29Labeling · Supplement 56AP
1979-08-23Labeling · Supplement 53AP
1979-08-23Labeling · Supplement 52AP
1979-08-15Labeling · Supplement 51AP
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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