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Metformin Hydrochloride

ANDA 200690, held by Mylan Pharms Inc. Metformin Hydrochloride.

  • First approved: Aug 1, 2012
  • Supplements approved: 4
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below
DateSubmissionStatusDocuments
Aug 1, 2012Original applicationApprovedNone posted

Products

2 strengths and forms
ProductActive ingredientMarketing
Metformin Hydrochloride500MG · tablet, extended release;oralMetformin HydrochlorideRx
Metformin Hydrochloride1GM · tablet, extended release;oralMetformin HydrochlorideRx
All 5 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Aug 11, 2026Supplement 16Labeling · Standard reviewApprovedNone posted
Jun 26, 2026Supplement 4Labeling · Standard reviewApprovedNone posted
Jun 26, 2026Supplement 5Labeling · Standard reviewApprovedNone posted
Mar 7, 2016Supplement 2ManufacturingApprovedNone posted
Aug 1, 2012Original applicationApprovedNone posted

Identifiers

Application
ANDA 200690

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.