FDA NDA · NDA008578

PYRIMETHAMINE

Sponsor: TILDE SCIENCES

APPLICATION

NDA008578

TYPE

NDA

ORIGINAL APPROVAL

1953-01-23

LATEST ACTION

2017-06-21

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

DARAPRIM · ReferencePrescription

PYRIMETHAMINE 25MG · TABLET · ORAL

2017-06-21Labeling · Supplement 20 · standard — Label ↗AP

2017-03-16Labeling · Supplement 19 · standard — Label ↗AP

2003-11-18Labeling · Supplement 16 · standard — Letter ↗AP

2002-10-10Labeling · Supplement 15 · standard — Letter ↗AP

1998-04-08Labeling · Supplement 14 · standardAP

1998-04-08Labeling · Supplement 10AP

1997-03-25Labeling · Supplement 13 · standardAP

1988-10-17Labeling · Supplement 9AP

1987-02-20Labeling · Supplement 8AP

1953-01-23Type 1 - New Molecular Entity · Original · priority — Label ↗AP

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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