← FDA DRUG APPROVALS

FDA NDA · NDA016949

LIMBITROL

Sponsor: CHARTWELL RX

APPLICATION
NDA016949
TYPE
NDA
ORIGINAL APPROVAL
1977-12-23
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LIMBITROL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE EQ 12.5MG BASE, CHLORDIAZEPOXIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LIMBITROL DS · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE EQ 25MG BASE, CHLORDIAZEPOXIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-06-24Labeling · Supplement 44 · standard — Letter ↗AP
2024-10-28Labeling · Supplement 43 · standard — Label ↗AP
2023-01-13Labeling · Supplement 42 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 41 · 901 required — Letter ↗AP
2016-12-16Labeling · Supplement 40 · 901 required — Label ↗AP
2016-04-25Labeling · Supplement 39 · 901 required — Label ↗AP
2007-08-03Labeling · Supplement 38 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 35 · standard — Letter ↗AP
2001-12-19Manufacturing (CMC) · Supplement 34 · standardAP
2001-06-05Labeling · Supplement 33 · standard — Letter ↗AP
2000-03-28Labeling · Supplement 27AP
2000-03-28Labeling · Supplement 31 · standardAP
2000-03-28Labeling · Supplement 32 · standardAP
1992-12-28Manufacturing (CMC) · Supplement 29 · standardAP
1990-01-16Manufacturing (CMC) · Supplement 28 · standardAP
1988-06-09Manufacturing (CMC) · Supplement 26 · standardAP
1985-11-19Labeling · Supplement 25AP
1985-04-17Labeling · Supplement 24AP
1984-06-26Manufacturing (CMC) · Supplement 22 · standardAP
1982-09-20Manufacturing (CMC) · Supplement 19 · standardAP
1982-09-20Manufacturing (CMC) · Supplement 20 · standardAP
1982-03-22Manufacturing (CMC) · Supplement 18 · standardAP
1980-09-09Manufacturing (CMC) · Supplement 2 · standardAP
1980-09-09Manufacturing (CMC) · Supplement 3 · standardAP
1980-09-09Manufacturing (CMC) · Supplement 1 · standardAP
1980-05-19Manufacturing (CMC) · Supplement 14 · standardAP
1980-05-19Manufacturing (CMC) · Supplement 12 · standardAP
1980-03-28Labeling · Supplement 13AP
1980-01-21Manufacturing (CMC) · Supplement 11 · standardAP
1979-09-07Manufacturing (CMC) · Supplement 8 · standardAP
1979-08-15Manufacturing (CMC) · Supplement 10 · standardAP
1978-09-25Labeling · Supplement 9AP
1978-08-22Manufacturing (CMC) · Supplement 6 · standardAP
1978-07-24Manufacturing (CMC) · Supplement 5 · standardAP
1978-04-17Manufacturing (CMC) · Supplement 4 · standardAP
1977-12-23Type 4 - New Combination · Original · standard — Other Important Information from FDA ↗AP
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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