Viewing data from:

RAMELTEON

ANDA

RAMELTEON | A215485 | HIBROW HEALTHCARE PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ROZEREM(TE code: AB)

API Supply Chain7 active DMFs

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

TAPI NL BVRAMELTEON

DMF 228822009

MSN LABORATORIES PRIVATE LTDRAMELTEON

DMF 315062017

SS PHARMA LLCRAMELTEON

DMF 324442018

ENALTEC LABS PRIVATE LTDRAMELTEON

DMF 336012019

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDRAMELTEON

DMF 337192019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRAMELTEON

DMF 344142019

APITORIA PHARMA PRIVATE LTDRAMELTEON

DMF 348992020

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

Products (1)

#001 — 8MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 4, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Hibrow Healthcare's ramelteon product (NDA 215485, Strength 001) was added to the FDA product database.

New: New record