Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091326
Company: PADDOCK LLC
Company: PADDOCK LLC
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 |
---|---|---|---|---|---|---|---|
07/08/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091326s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/19/2020 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
10/05/2015 | SUPPL-3 | Labeling-Patient Package Insert, 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 |
---|---|---|---|---|---|---|---|---|
AMERGE | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020763 | GLAXOSMITHKLINE LLC |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 200502 | HERITAGE PHARMS INC |
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 | ORCHID HLTHCARE |
NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 091326 | PADDOCK LLC |
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 | 090381 | HIKMA |
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 |
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