Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201573
Company: ANCHEN PHARMS
Company: ANCHEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 07/18/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201573Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/29/2020 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf |
FENOFIBRIC ACID
CAPSULE, DELAYED RELEASE;ORAL; EQ 135MG FENOFIBRIC ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 200920 | ACTAVIS ELIZABETH |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 211626 | ADAPTIS |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 208705 | ALEMBIC PHARMS LTD |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 201573 | ANCHEN PHARMS |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 212598 | AUROBINDO PHARMA LTD |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 200264 | IMPAX LABS INC |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 200750 | LUPIN LTD |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 213450 | MICRO LABS |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210469 | TWI PHARMS |
| TRILIPIX | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022224 | ABBVIE |
CAPSULE, DELAYED RELEASE;ORAL; EQ 45MG FENOFIBRIC ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 200920 | ACTAVIS ELIZABETH |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 211626 | ADAPTIS |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 208705 | ALEMBIC PHARMS LTD |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 201573 | ANCHEN PHARMS |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 212598 | AUROBINDO PHARMA LTD |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 200264 | IMPAX LABS INC |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 200750 | LUPIN LTD |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 213450 | MICRO LABS |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210469 | TWI PHARMS |
| TRILIPIX | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022224 | ABBVIE |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English