Drugs@FDA: FDA-Approved Drugs
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
06/17/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/28/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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07/28/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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07/28/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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01/29/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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01/29/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
LAMOTRIGINE
TABLET, ORALLY DISINTEGRATING;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL ODT | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL ODT | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL ODT | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL ODT | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | ENDO OPERATIONS |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |