Drugs@FDA: FDA-Approved Drugs
Company: ZYDUS PHARMS USA 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 |
---|---|---|---|---|---|---|---|
02/11/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/03/2024 | SUPPL-19 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/09/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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10/28/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/28/2020 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/28/2020 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/28/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/28/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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11/08/2014 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/08/2014 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/11/2012 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/30/2011 | SUPPL-1 | 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 |