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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#Isoniazid ×

UPDATED
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
FDA Approves Manufacturing Supplements for Isoniazid (ANDA080132)
FDA approved three manufacturing supplement submissions for Isoniazid tablets (50 mg and 100 mg) under ANDA080132; both products are listed as discontinued.
UPDATED
Regulatorische Updates
16. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA 088119 for Isoniazid 300 mg Tablet
The FDA approved application ANDA088119 for an oral Isoniazid 300 mg tablet marketed by Duramed Pharms Barr. The product is listed as discontinued and includes a detailed submission history.
UPDATED
Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA085790 for Isoniazid 100 mg Tablet by Watson Labs
The FDA has approved ANDA085790 for an oral 100 mg Isoniazid tablet submitted by Watson Labs. The product is currently listed as discontinued.
UPDATED
Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
Quad Pharms Isoniazid Injection (100 mg/mL) Listed as Discontinued in FDA ANDA089816
FDA records show Quad Pharms' Isoniazid injectable (100 mg/mL) under ANDA089816 is marked as discontinued.
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UPDATED
Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
FDA Discontinues Isoniazid Oral Tablet (ANDA083632)
The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Discontinues Isoniazid Tablet (ANDA083060)
FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA080126 for STANOZIDE Isoniazid Tablets (Everylife)
The FDA approved ANDA080126 on Jan 21 1972 for Everylife's STANOZIDE oral tablets containing 100 mg and 300 mg of isoniazid, both now listed as discontinued.