Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205101
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | AB1 | No | No |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 02/04/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205101Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/29/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2017 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
GABAPENTIN
TABLET;ORAL; 600MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 075694 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 206402 | ALKEM LABS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 214957 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 200651 | AUROBINDO PHARMA LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 207057 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 077662 | GLENMARK PHARMS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 217116 | GRANULES |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 209855 | IPCA LABS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 217965 | LAURUS |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 217995 | RISING |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 077661 | RUBICON |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 205101 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 203244 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 211313 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 077525 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB1 | 078926 | ZYDUS PHARMS USA INC |
| NEURONTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | Yes | AB1 | 020882 | VIATRIS |
TABLET;ORAL; 800MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 075694 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 206402 | ALKEM LABS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 214957 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 200651 | AUROBINDO PHARMA LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 207057 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 077662 | GLENMARK PHARMS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 217116 | GRANULES |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 209855 | IPCA LABS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 217965 | LAURUS |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 217995 | RISING |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 077661 | RUBICON |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 205101 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 203244 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 211313 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 077525 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | No | AB1 | 078926 | ZYDUS PHARMS USA INC |
| NEURONTIN | GABAPENTIN | 800MG | TABLET;ORAL | Prescription | Yes | AB1 | 020882 | VIATRIS |