Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207016
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | AB | No | No |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | AB | No | No |
TELMISARTAN | TELMISARTAN | 80MG | 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 |
---|---|---|---|---|---|---|---|
10/03/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207016Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/08/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/04/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
TELMISARTAN
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | Yes | AB | 020850 | BOEHRINGER INGELHEIM |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 202130 | ALEMBIC |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 204415 | AMNEAL PHARMS |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 206511 | AUROBINDO PHARMA |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208605 | CADILA PHARMS LTD |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 078710 | CHARTWELL RX |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 090032 | GLENMARK PHARMS LTD |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 205901 | HETERO LABS LTD V |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 205150 | INVENTIA |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 207016 | MICRO LABS |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 202397 | MYLAN |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 207882 | PRINSTON INC |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 203867 | SANDOZ |
TELMISARTAN | TELMISARTAN | 20MG | TABLET;ORAL | Prescription | No | AB | 203325 | ZYDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | Yes | AB | 020850 | BOEHRINGER INGELHEIM |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 202130 | ALEMBIC |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204415 | AMNEAL PHARMS |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 206511 | AUROBINDO PHARMA |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 208605 | CADILA PHARMS LTD |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 078710 | CHARTWELL RX |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 090032 | GLENMARK PHARMS LTD |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 205901 | HETERO LABS LTD V |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 205150 | INVENTIA |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 207016 | MICRO LABS |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 202397 | MYLAN |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 207882 | PRINSTON INC |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 203867 | SANDOZ |
TELMISARTAN | TELMISARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 203325 | ZYDUS PHARMS |
TABLET;ORAL; 80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | Yes | AB | 020850 | BOEHRINGER INGELHEIM |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 202130 | ALEMBIC |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204415 | AMNEAL PHARMS |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 206511 | AUROBINDO PHARMA |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 208605 | CADILA PHARMS LTD |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 078710 | CHARTWELL RX |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 090032 | GLENMARK PHARMS LTD |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 205901 | HETERO LABS LTD V |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 205150 | INVENTIA |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 207016 | MICRO LABS |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 202397 | MYLAN |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 207882 | PRINSTON INC |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 203867 | SANDOZ |
TELMISARTAN | TELMISARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 203325 | ZYDUS PHARMS |