Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206432
Company: CADILA PHARMS LTD
Company: CADILA PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | AB | No | No |
NATEGLINIDE | NATEGLINIDE | 120MG | 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 |
---|---|---|---|---|---|---|---|
04/19/2019 | 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 |
---|---|---|---|---|---|
01/19/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
NATEGLINIDE
TABLET;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 206432 | CADILA PHARMS LTD |
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 077461 | DR REDDYS LABS LTD |
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 205544 | RISING PHARMA |
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 077463 | STRIDES PHARMA |
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 077462 | WATSON LABS |
NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 205248 | ZYDUS PHARMS |
TABLET;ORAL; 120MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NATEGLINIDE | NATEGLINIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 206432 | CADILA PHARMS LTD |
NATEGLINIDE | NATEGLINIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 077461 | DR REDDYS LABS LTD |
NATEGLINIDE | NATEGLINIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 205544 | RISING PHARMA |
NATEGLINIDE | NATEGLINIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 077463 | STRIDES PHARMA |
NATEGLINIDE | NATEGLINIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 077462 | WATSON LABS |
NATEGLINIDE | NATEGLINIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 205248 | ZYDUS PHARMS |