Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090745
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 12/11/2013 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090745Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/02/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-19 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021427 | LILLY |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090776 | ACTAVIS ELIZABETH |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208706 | AJANTA PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202949 | ALEMBIC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203197 | ALKEM LABS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090780 | ANCHEN PHARMS |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202045 | APOTEX |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090778 | AUROBINDO PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203088 | BRECKENRIDGE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211310 | CSPC OUYI |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204343 | HETERO LABS LTD III |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202336 | INVENTIA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090694 | LUPIN LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204815 | MACLEODS PHARMS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090723 | MARKSANS PHARMA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206653 | PRINSTON INC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210599 | QINGDAO BAHEAL PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090745 | SUN PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212328 | SUNSHINE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090774 | TORRENT |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090739 | ZYDUS HLTHCARE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090728 | ZYDUS PHARMS |
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021427 | LILLY |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090776 | ACTAVIS ELIZABETH |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208706 | AJANTA PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202949 | ALEMBIC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203197 | ALKEM LABS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090780 | ANCHEN PHARMS |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202045 | APOTEX |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090778 | AUROBINDO PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203088 | BRECKENRIDGE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211310 | CSPC OUYI |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204343 | HETERO LABS LTD III |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202336 | INVENTIA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090694 | LUPIN LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204815 | MACLEODS PHARMS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090723 | MARKSANS PHARMA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206653 | PRINSTON INC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210599 | QINGDAO BAHEAL PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090745 | SUN PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212328 | SUNSHINE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090774 | TORRENT |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090739 | ZYDUS HLTHCARE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090728 | ZYDUS PHARMS |
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 60MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021427 | LILLY |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090776 | ACTAVIS ELIZABETH |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208706 | AJANTA PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202949 | ALEMBIC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203197 | ALKEM LABS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090780 | ANCHEN PHARMS |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202045 | APOTEX |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090778 | AUROBINDO PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203088 | BRECKENRIDGE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211310 | CSPC OUYI |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204343 | HETERO LABS LTD III |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202336 | INVENTIA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090694 | LUPIN LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204815 | MACLEODS PHARMS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090723 | MARKSANS PHARMA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206653 | PRINSTON INC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210599 | QINGDAO BAHEAL PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090745 | SUN PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212328 | SUNSHINE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090774 | TORRENT |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090739 | ZYDUS HLTHCARE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090728 | ZYDUS PHARMS |