Vantrela Er

NDA 207975, held by Teva Branded Pharm. Hydrocodone Bitartrate.

As of Nov 13, 2026, NDA 207975 (Vantrela Er), held by Teva Branded Pharm, was first approved by FDA on Jan 17, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 17, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 17, 2017	Original applicationNew dosage form · Standard review	Approved	Review REMS Medication Guide Letter

Products

5 strengths and forms


Vantrela Er15MG · tablet, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Vantrela Er30MG · tablet, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Vantrela Er45MG · tablet, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Vantrela Er60MG · tablet, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Vantrela Er90MG · tablet, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


May 26, 2017	Supplement 2REMS	Approved	Letter
Jan 17, 2017	Original applicationNew dosage form · Standard review	Approved	Review REMS Medication Guide Letter

Identifiers

Application: NDA 207975
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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