← FDA DRUG APPROVALS

FDA NDA · NDA203696

LUPANETA PACK

Sponsor: ABBVIE ENDOCRINE

APPLICATION
NDA203696
TYPE
NDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2023-08-09
ROUTE
INTRAMUSCULAR, ORAL
DOSAGE FORM
INJECTABLE, TABLET
MARKETING STATUS
Discontinued

Products

LUPANETA PACK · ReferenceDiscontinued
LEUPROLIDE ACETATE 3.75MG/VIAL,N/A, NORETHINDRONE ACETATE N/A,5MG · INJECTABLE, TABLET · INTRAMUSCULAR, ORAL
LUPANETA PACK · ReferenceDiscontinued
LEUPROLIDE ACETATE 11.25MG/VIAL,N/A, NORETHINDRONE ACETATE N/A,5MG · INJECTABLE, TABLET · INTRAMUSCULAR, ORAL

Approval history

2023-08-09Labeling · Supplement 6 · standard — Letter ↗AP
2023-08-09Labeling · Supplement 5 · standard — Letter ↗AP
2023-01-31Labeling · Supplement 7 · standard — Letter ↗AP
2014-04-29Manufacturing (CMC) · Supplement 3 · standardAP
2013-11-20Manufacturing (CMC) · Supplement 2 · standardAP
2013-10-30Labeling · Supplement 1 · standard — Label ↗AP
2012-12-14Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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