Details for New Drug Application (NDA): 216620
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NDA 216620 describes ELTROMBOPAG OLAMINE, which is a drug marketed by Annora Pharma and Hetero Labs Ltd V and is included in two NDAs. It is available from two suppliers. Additional details are available on the ELTROMBOPAG OLAMINE profile page.
The generic ingredient in ELTROMBOPAG OLAMINE is eltrombopag olamine. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
The generic ingredient in ELTROMBOPAG OLAMINE is eltrombopag olamine. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 216620
| Tradename: | ELTROMBOPAG OLAMINE |
| Applicant: | Annora Pharma |
| Ingredient: | eltrombopag olamine |
| Patents: | 0 |
Pharmacology for NDA: 216620
Suppliers and Packaging for NDA: 216620
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | eltrombopag olamine | FOR SUSPENSION;ORAL | 216620 | ANDA | Camber Pharmaceuticals, Inc. | 31722-300 | 31722-300-32 | 1 CARTON in 1 KIT (31722-300-32) / 30 PACKET in 1 CARTON (31722-300-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-300-12) |
| ELTROMBOPAG OLAMINE | eltrombopag olamine | FOR SUSPENSION;ORAL | 216620 | ANDA | Camber Pharmaceuticals, Inc. | 31722-301 | 31722-301-32 | 1 CARTON in 1 KIT (31722-301-32) / 30 PACKET in 1 CARTON (31722-301-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-301-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 12.5MG ACID/PACKET | ||||
| Approval Date: | Apr 18, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 25MG ACID/PACKET | ||||
| Approval Date: | Apr 18, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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