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FDA NDA · NDA006134

DOLOPHINE HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
NDA006134
TYPE
NDA
ORIGINAL APPROVAL
1947-08-13
LATEST ACTION
2021-06-02
ROUTE
ORAL
DOSAGE FORM
SYRUP, TABLET
MARKETING STATUS
Discontinued

Products

DOLOPHINE HYDROCHLORIDEDiscontinued
METHADONE HYDROCHLORIDE 10MG/30ML · SYRUP · ORAL
DOLOPHINE HYDROCHLORIDE · ReferenceDiscontinued
METHADONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DOLOPHINE HYDROCHLORIDE · ReferenceDiscontinued
METHADONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-06-02Labeling · Supplement 50 · standard — Label ↗AP
2019-10-07Labeling · Supplement 49 · standard — Label ↗AP
2018-09-18Labeling · Supplement 48 · standard — Letter ↗AP
2018-09-18REMS · Supplement 46 — Letter ↗AP
2018-02-01Labeling · Supplement 45 · standard — Label ↗AP
2017-05-26REMS · Supplement 44 — Letter ↗AP
2016-12-16Labeling · Supplement 40 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 41 · standard — Letter ↗AP
2016-09-30REMS · Supplement 42 — Letter ↗AP
2016-04-20REMS · Supplement 39 — Letter ↗AP
2015-06-26REMS · Supplement 37 — Letter ↗AP
2015-04-02Labeling · Supplement 38 · standard — Letter ↗AP
2014-08-19REMS · Supplement 36 — Letter ↗AP
2014-04-16Labeling · Supplement 35 · 901 required — Letter ↗AP
2013-04-15REMS · Supplement 32 — Letter ↗AP
2012-07-09Labeling · Supplement 30 · unknown — Letter ↗AP
2012-07-09REMS · Supplement 31 — Label ↗AP
2006-11-17Labeling · Supplement 28 · standard — Letter ↗AP
2000-10-17Labeling · Supplement 23 · standardAP
2000-05-05Manufacturing (CMC) · Supplement 27AP
1999-03-30Manufacturing (CMC) · Supplement 26AP
1999-03-12Labeling · Supplement 17AP
1998-11-12Manufacturing (CMC) · Supplement 25AP
1996-10-15Manufacturing (CMC) · Supplement 24AP
1995-02-21Manufacturing (CMC) · Supplement 22AP
1994-05-11Manufacturing (CMC) · Supplement 21AP
1987-08-13Labeling · Supplement 15AP
1986-01-10Labeling · Supplement 13AP
1981-10-16Manufacturing (CMC) · Supplement 12AP
1980-02-01Manufacturing (CMC) · Supplement 9AP
1977-01-05Labeling · Supplement 8AP
1947-08-13UNKNOWN · Original · unknown — 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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