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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202595
Company: NATCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription AB No No
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription AB No No
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/03/2016 ORIG-1 Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202595Orig1s000lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2021 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/09/2021 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/09/2021 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202595Orig1s000lbl.pdf

OSELTAMIVIR PHOSPHATE

CAPSULE;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 214726 ACCORD HLTHCARE
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 211823 ALEMBIC PHARMS LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 209093 AMNEAL PHARMS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 215208 EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 209438 HETERO LABS LTD III
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 208348 LUPIN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 207211 MACLEODS PHARMS LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 212544 MSN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 202595 NATCO
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 209421 STRIDES PHARMA
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription No AB 208578 ZYDUS PHARMS
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 30MG BASE CAPSULE;ORAL Prescription Yes AB 021087 ROCHE

CAPSULE;ORAL; EQ 45MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 214726 ACCORD HLTHCARE
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 211823 ALEMBIC PHARMS LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 209093 AMNEAL PHARMS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 215208 EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 209438 HETERO LABS LTD III
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 208348 LUPIN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 207211 MACLEODS PHARMS LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 212544 MSN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 202595 NATCO
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 209421 STRIDES PHARMA
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription No AB 208578 ZYDUS PHARMS
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 45MG BASE CAPSULE;ORAL Prescription Yes AB 021087 ROCHE

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 214726 ACCORD HLTHCARE
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 211823 ALEMBIC PHARMS LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209093 AMNEAL PHARMS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 215208 EPIC PHARMA LLC
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209438 HETERO LABS LTD III
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 208348 LUPIN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 207211 MACLEODS PHARMS LTD
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 212544 MSN
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 202595 NATCO
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209421 STRIDES PHARMA
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 208578 ZYDUS PHARMS
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 75MG BASE CAPSULE;ORAL Prescription Yes AB 021087 ROCHE
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