← FDA DRUG APPROVALS

FDA NDA · NDA209844

LYMEPAK

Sponsor: CHARTWELL PHARMA

APPLICATION
NDA209844
TYPE
NDA
ORIGINAL APPROVAL
2018-06-15
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LYMEPAK · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET · ORAL

Approval history

2025-03-31Labeling · Supplement 2 · standard — Label ↗AP
2019-01-24Labeling · Supplement 1 · standard — Label ↗AP
2018-06-15Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →