Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077463
Company: STRIDES PHARMA
Company: STRIDES PHARMA
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 |
---|---|---|---|---|---|---|---|
09/09/2009 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077463s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077463s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/13/2022 | SUPPL-12 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/13/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
10/13/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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07/30/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
07/30/2013 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/09/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf |
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 |
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 |
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 |