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FDA NDA · NDA008697

CORTEF

hydrocortisone

Sponsor: PHARMACIA AND UPJOHN

APPLICATION
NDA008697
TYPE
NDA
ORIGINAL APPROVAL
1952-12-15
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CORTEF · ReferencePrescription
HYDROCORTISONE 20MG · TABLET · ORAL
CORTEF · ReferencePrescription
HYDROCORTISONE 5MG · TABLET · ORAL
CORTEF · ReferencePrescription
HYDROCORTISONE 10MG · TABLET · ORAL

Approval history

2024-06-05Labeling · Supplement 40 · standard — Label ↗AP
2023-12-20Labeling · Supplement 38 · standard — Label ↗AP
2019-11-21Labeling · Supplement 36 · standard — Label ↗AP
2016-09-08Labeling · Supplement 33 · standard — Letter ↗AP
2016-09-08Labeling · Supplement 32 · standard — Letter ↗AP
2001-03-16Manufacturing (CMC) · Supplement 25 · standardAP
1993-12-28Labeling · Supplement 21 · standard — Label ↗AP
1993-12-08Manufacturing (CMC) · Supplement 20 · standardAP
1983-03-09Manufacturing (CMC) · Supplement 16 · standardAP
1978-02-08Labeling · Supplement 14AP
1952-12-15Type 5 - New Formulation or New Manufacturer · 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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