Orange Book product · Brand (NDA)
STARLIX
NATEGLINIDE
At a glance
Dec 22, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2000
25 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NATEGLINIDE
Strength
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021204
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019NATEGLINIDEGeneric (ANDA)
ANDA 206432 · CADILA PHARMS LTD
- 2018NATEGLINIDEGeneric (ANDA)
ANDA 205544 · RISING
- 2016NATEGLINIDEGeneric (ANDA)
ANDA 205248 · ZYDUS PHARMS
- 2015NATEGLINIDEGeneric (ANDA)
ANDA 205055 · ALVOGEN
- 2011NATEGLINIDEGeneric (ANDA)
ANDA 077462 · WATSON LABS
- 2009NATEGLINIDEGeneric (ANDA)
ANDA 077461 · DR REDDYS LABS LTD
- 2009NATEGLINIDEGeneric (ANDA)
ANDA 077463 · STRIDES PHARMA INTL
- 2009NATEGLINIDEGeneric (ANDA)
ANDA 077467 · TEVA PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
