Viewing data from:

VIGABATRIN

ANDA

VIGABATRIN | A211539 | DR REDDYS LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: SABRIL(TE code: AB)

API Supply Chain7 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDVIGABATRIN USP [ROUTE CODE - "VB"]

DMF 272402013

DIVIS LABORATORIES LTDVIGABATRIN USP

DMF 319532017

SIONC PHARMACEUTICALS PVT LTDVIGABATRIN

DMF 331542018

HETERO DRUGS LTDVIGABATRIN

DMF 332252018

APITORIA PHARMA PRIVATE LTDVIGABATRIN USP

DMF 337692019

METROCHEM API PRIVATE LTDVIGABATRIN USP

DMF 380892023

MSN LIFE SCIENCES PRIVATE LTDVIGABATRIN USP

DMF 405172024

DIVIS LABORATORIES LTDInactiveVIGABATRIN

DMF 215792008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 29, 2021

No patent or exclusivity listings for this strength.