Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216620
Company: ANNORA PHARMA
Company: ANNORA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID/PACKET | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
04/18/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216620Orig1s000TAltr.pdf |
ELTROMBOPAG OLAMINE
FOR SUSPENSION;ORAL; EQ 12.5MG ACID/PACKET
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/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 216620 | ANNORA PHARMA |
PROMACTA KIT | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 207027 | NOVARTIS |
FOR SUSPENSION;ORAL; EQ 25MG ACID/PACKET
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/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 216620 | ANNORA PHARMA |
PROMACTA KIT | ELTROMBOPAG OLAMINE | EQ 25MG ACID/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 207027 | NOVARTIS |