Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078199
Company: CHARTWELL
Company: CHARTWELL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG 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 |
---|---|---|---|---|---|---|---|
07/02/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078199s000_ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/28/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
02/28/2020 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2020 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/25/2015 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
02/19/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
07/12/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
TERBINAFINE HYDROCHLORIDE
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078297 | AUROBINDO PHARMA |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 077714 | BRECKENRIDGE PHARM |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078199 | CHARTWELL |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076390 | DR REDDYS LABS INC |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 077919 | EMED MEDCL |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078157 | GLENMARK PHARMS LTD |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 077533 | INVAGEN PHARMS |
TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 078163 | ORBION PHARMS |