Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Isoniazid ×
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
8 sept 2026•1 min de lectura
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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Actualizaciones regulatorias
8 sept 2026•1 min de lectura
FDA Discontinues Isoniazid Oral Tablet (ANDA083632)
The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Discontinues Isoniazid Tablet (ANDA083060)
FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
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.