Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219638
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | AB | No | No |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | AB | No | No |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | AB | No | No |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | AB | No | No |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | 25MG | TABLET | None (Tentative Approval) | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ELTROMBOPAG OLAMINE
TABLET;ORAL; EQ 12.5MG ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 212884 | AMNEAL |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 220660 | BIOCON PHARMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 219121 | DR REDDYS |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 206788 | HETERO LABS LTD V |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 220033 | HIKMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 220250 | MSN |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 219638 | SOMERSET THERAPS LLC |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | No | AB | 216281 | ZYDUS PHARMS |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET;ORAL | Prescription | Yes | AB | 022291 | NOVARTIS |
TABLET;ORAL; EQ 25MG ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 212884 | AMNEAL |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 220660 | BIOCON PHARMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 219121 | DR REDDYS |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 206788 | HETERO LABS LTD V |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 220033 | HIKMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 220250 | MSN |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 219638 | SOMERSET THERAPS LLC |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | No | AB | 216281 | ZYDUS PHARMS |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET;ORAL | Prescription | Yes | AB | 022291 | NOVARTIS |
TABLET;ORAL; EQ 50MG ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 212884 | AMNEAL |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 220660 | BIOCON PHARMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 219121 | DR REDDYS |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 206788 | HETERO LABS LTD V |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 220033 | HIKMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 220250 | MSN |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 219638 | SOMERSET THERAPS LLC |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | No | AB | 216281 | ZYDUS PHARMS |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET;ORAL | Prescription | Yes | AB | 022291 | NOVARTIS |
TABLET;ORAL; EQ 75MG ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 212884 | AMNEAL |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 220660 | BIOCON PHARMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 219121 | DR REDDYS |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 206788 | HETERO LABS LTD V |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 220033 | HIKMA |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 220250 | MSN |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 219638 | SOMERSET THERAPS LLC |
| ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | No | AB | 216281 | ZYDUS PHARMS |
| PROMACTA | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET;ORAL | Prescription | Yes | AB | 022291 | NOVARTIS |