Details for New Drug Application (NDA): 206788
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NDA 206788 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 206788
| Tradename: | ELTROMBOPAG OLAMINE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | eltrombopag olamine |
| Patents: | 0 |
Pharmacology for NDA: 206788
Suppliers and Packaging for NDA: 206788
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | eltrombopag olamine | TABLET;ORAL | 206788 | ANDA | Camber Pharmaceuticals, Inc. | 31722-841 | 31722-841-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-841-30) |
| ELTROMBOPAG OLAMINE | eltrombopag olamine | TABLET;ORAL | 206788 | ANDA | Camber Pharmaceuticals, Inc. | 31722-842 | 31722-842-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-842-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG ACID | ||||
| Approval Date: | Jan 17, 2025 | 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: | TABLET;ORAL | Strength | EQ 25MG ACID | ||||
| Approval Date: | Jan 17, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG ACID | ||||
| Approval Date: | Jan 17, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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