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Promethazine Hydrochloride

ANDA 40737, held by Xgen Pharms. Promethazine Hydrochloride.

  • First approved: Apr 24, 2008
  • Supplements approved: 2
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below
DateSubmissionStatusDocuments
Apr 24, 2008Original applicationApprovedNone posted

Products

2 strengths and forms
ProductActive ingredientMarketing
Promethazine Hydrochloride25MG/ML · injectable;injectionPromethazine HydrochlorideRx
Promethazine Hydrochloride50MG/ML · injectable;injectionPromethazine HydrochlorideRx
All 3 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Dec 27, 2023Supplement 8Labeling · Standard reviewApprovedNone posted
Nov 19, 2009Supplement 1LabelingApprovedNone posted
Apr 24, 2008Original applicationApprovedNone posted

Identifiers

Application
ANDA 40737

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.