Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 091552
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 02/14/2011 | 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 |
|---|---|---|---|---|---|
| 09/22/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2013 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
NARATRIPTAN
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMERGE | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020763 | GLAXOSMITHKLINE LLC |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 200502 | HERITAGE PHARMS INC |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 202431 | MYLAN PHARMS INC |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 091441 | ORCHID HLTHCARE |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 091326 | PADDOCK LLC |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 091552 | SUN PHARM INDS LTD |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078751 | TEVA PHARMS |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090381 | WEST-WARD PHARMS INT |
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