Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090381
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | No | No |
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 |
---|---|---|---|---|---|---|---|
07/07/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090381s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/11/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NARATRIPTAN
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 200502 | HERITAGE |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 090381 | HIKMA |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 091441 | ORBION PHARMS |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 091326 | PADAGIS US |
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 |
---|---|---|---|---|---|---|---|---|
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 200502 | HERITAGE |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090381 | HIKMA |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 091441 | ORBION PHARMS |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 091326 | PADAGIS US |