Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206367
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | 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 |
---|---|---|---|---|---|---|---|
12/10/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206367Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
AMLODIPINE BESYLATE
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 202553 | ACCORD HLTHCARE |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078925 | ALKEM |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078021 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 076692 | CHARTWELL RX |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090752 | CHINA RESOURCES |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 077073 | CIPLA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 076719 | COREPHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078552 | EPIC PHARMA LLC |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 077955 | INVAGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206367 | INVAGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078453 | ORBION PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078414 | OXFORD PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 207821 | POLYGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 077516 | STRIDES PHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 076846 | TEVA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 203245 | UNICHEM |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078226 | ZYDUS PHARMS USA |
NORVASC | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019787 | VIATRIS |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202553 | ACCORD HLTHCARE |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078925 | ALKEM |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078021 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 076692 | CHARTWELL RX |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090752 | CHINA RESOURCES |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077073 | CIPLA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 076719 | COREPHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078552 | EPIC PHARMA LLC |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077955 | INVAGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206367 | INVAGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078453 | ORBION PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078414 | OXFORD PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207821 | POLYGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077516 | STRIDES PHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 076846 | TEVA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203245 | UNICHEM |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078226 | ZYDUS PHARMS USA |
NORVASC | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019787 | VIATRIS |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202553 | ACCORD HLTHCARE |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078925 | ALKEM |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078021 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076692 | CHARTWELL RX |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090752 | CHINA RESOURCES |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077073 | CIPLA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076719 | COREPHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078552 | EPIC PHARMA LLC |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077955 | INVAGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206367 | INVAGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078453 | ORBION PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078414 | OXFORD PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207821 | POLYGEN PHARMS |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077516 | STRIDES PHARMA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076846 | TEVA |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203245 | UNICHEM |
AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078226 | ZYDUS PHARMS USA |
NORVASC | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019787 | VIATRIS |