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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205192
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;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
04/24/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2022 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

OLMESARTAN MEDOXOMIL

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription Yes AB 021286 COSETTE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 207662 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 203012 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 206763 ALKEM LABS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 204798 AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 203281 GLENMARK PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 204814 MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 206372 MICRO LABS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 210552 QILU
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 090237 SANDOZ INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 208130 SCIEGEN PHARMS INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 211049 SUNSHINE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 202375 TORRENT
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 207135 UMEDICA LABS PVT LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET;ORAL Prescription No AB 205192 ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription Yes AB 021286 COSETTE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 207662 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 203012 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 206763 ALKEM LABS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 204798 AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 203281 GLENMARK PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 204814 MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 206372 MICRO LABS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 210552 QILU
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 090237 SANDOZ INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 208130 SCIEGEN PHARMS INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 211049 SUNSHINE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 202375 TORRENT
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 207135 UMEDICA LABS PVT LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET;ORAL Prescription No AB 205192 ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription Yes AB 021286 COSETTE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 207662 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 203012 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 206763 ALKEM LABS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 204798 AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 203281 GLENMARK PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 204814 MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 206372 MICRO LABS
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 210552 QILU
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 090237 SANDOZ INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 208130 SCIEGEN PHARMS INC
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 211049 SUNSHINE
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 202375 TORRENT
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 207135 UMEDICA LABS PVT LTD
OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET;ORAL Prescription No AB 205192 ZYDUS PHARMS
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