Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/12/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075350_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/26/2021 | SUPPL-67 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/21/2020 | SUPPL-66 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/21/2020 | SUPPL-60 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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01/13/2016 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
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03/16/2015 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
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01/13/2016 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
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04/11/2012 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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08/28/2012 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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06/24/2011 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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06/24/2011 | SUPPL-28 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
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05/13/2010 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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12/05/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
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12/23/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/08/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
GABAPENTIN
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206943 | ACI |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 075350 | ACTAVIS ELIZABETH |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090858 | ALKEM |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078428 | AMNEAL PHARMS NY |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214956 | ASCENT PHARMS INC |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078787 | AUROBINDO PHARMA |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 075477 | CSPC OUYI |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 075360 | GRANULES |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207099 | GRAVITI PHARMS |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208928 | IPCA LABS LTD |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 217546 | LAURUS |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090007 | MARKSANS PHARMA |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 204989 | SCIEGEN PHARMS INC |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077242 | SUN PHARM INDS LTD |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077261 | TARO |
GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
NEURONTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
CAPSULE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 206943 | ACI |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075350 | ACTAVIS ELIZABETH |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090858 | ALKEM |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 078428 | AMNEAL PHARMS NY |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214956 | ASCENT PHARMS INC |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 078787 | AUROBINDO PHARMA |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075477 | CSPC OUYI |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075360 | GRANULES |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 207099 | GRAVITI PHARMS |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 208928 | IPCA LABS LTD |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 217546 | LAURUS |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090007 | MARKSANS PHARMA |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 204989 | SCIEGEN PHARMS INC |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 077242 | SUN PHARM INDS LTD |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 077261 | TARO |
GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
NEURONTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
CAPSULE;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 206943 | ACI |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 075350 | ACTAVIS ELIZABETH |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090858 | ALKEM |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 078428 | AMNEAL PHARMS NY |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 214956 | ASCENT PHARMS INC |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 078787 | AUROBINDO PHARMA |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 075477 | CSPC OUYI |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 075360 | GRANULES |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 207099 | GRAVITI PHARMS |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 208928 | IPCA LABS LTD |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 217546 | LAURUS |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090007 | MARKSANS PHARMA |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 204989 | SCIEGEN PHARMS INC |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 077242 | SUN PHARM INDS LTD |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 077261 | TARO |
GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
NEURONTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |