Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200651
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | AB | No | No |
| GABAPENTIN | GABAPENTIN | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/15/2021 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2020 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/19/2020 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/19/2020 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2015 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/23/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
GABAPENTIN
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 203244 | ACI |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075694 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 206402 | ALKEM LABS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 214957 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 200651 | AUROBINDO PHARMA LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 207057 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 077662 | GLENMARK PHARMS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 202764 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 077661 | RUBICON |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 205101 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 077525 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB | 078926 | ZYDUS PHARMS USA INC |
| NEURONTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | Yes | AB | 020882 | VIATRIS |
TABLET;ORAL; 800MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 203244 | ACI |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 075694 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 206402 | ALKEM LABS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 214957 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 200651 | AUROBINDO PHARMA LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 207057 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 077662 | GLENMARK PHARMS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 202764 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 077661 | RUBICON |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 205101 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 077525 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB | 078926 | ZYDUS PHARMS USA INC |
| NEURONTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | Yes | AB | 020882 | VIATRIS |
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