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OSELTAMIVIR PHOSPHATE

ANDA

OSELTAMIVIR PHOSPHATE | A209438 | HETERO LABS LTD UNIT III

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TAMIFLU(TE code: AB)

API Supply Chain23 active DMFs

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

CIPLA LTDOSELTAMIVIR PHOSPHATE USP

DMF 215572008

SOLARA ACTIVE PHARMA SCIENCES LTDOSELTAMIVIR PHOSPHATE

DMF 229262009

MSN PHARMACHEM PRIVATE LTDOSELTAMIVIR PHOSPHATE [ROUTE CODE - "OT"]

DMF 238892010

MACLEODS PHARMACEUTICALS LTDOSELTAMIVIR PHOSPHATE

DMF 275332013

MATRIX PHARMACORP PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 300122015

LUPIN LTDOSELTAMIVIR PHOSPHATE USP

DMF 302532016

HETERO LABS LTDOSELTAMIVIR PHOSPHATE

DMF 304122016

RAKS PHARMA PVT LTDOSELTAMIVIR PHOSPHATE USP

DMF 333732018

LAURUS LABS LTDOSELTAMIVIR PHOSPHATE USP

DMF 337672020

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 339072020

INNOVARE LABS PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 347752020

AMPAC FINE CHEMICALS LLCOSELTAMIVIR PHOSPHATE DRUG SUBSTANCE

DMF 352342021

MSN LIFE SCIENCES PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 354092020

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 355142021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDOSELTAMIVIR PHOSPHATE

DMF 358762021

AZICO BIOPHORE INDIA PRIVATE LTDOSELTAMIVIR PHOSPHATE

DMF 361832021

CHROMO LABORATORIES INDIA PRIVATE LTDOSELTAMIVIR PHOSPHATE USP

DMF 369712022

ZYDUS LIFESCIENCES LTDOSELTAMIVIR PHOSPHATE USP

DMF 376772022

RUYUAN HEC PHARM CO LTDOSELTAMIVIR PHOSPHATE NON-STERILE BULK DRUG SUBSTANCE

DMF 387162023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE USP

DMF 393142023

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 406032024

FUJIAN FUKANG PHARMACEUTICAL CO LTDOSELTAMIVIR PHOSPHATE

DMF 421352025

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)OSELTAMIVIR PHOSPHATE USP

DMF 432362025

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

Products (3)

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#001 — EQ 30MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 23, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 45MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 23, 2018

#003 — EQ 75MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 23, 2018