NDC 73362-004

Skytrofa

Lonapegsomatropin-tcgd

Skytrofa is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Ascendis Pharma Endocrinology, Inc.. The primary component is Lonapegsomatropin.

Product ID73362-004_4daa329b-dc87-47b4-973c-026aabc815de
NDC73362-004
Product TypeHuman Prescription Drug
Proprietary NameSkytrofa
Generic NameLonapegsomatropin-tcgd
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2021-08-25
Marketing CategoryBLA /
Application NumberBLA761177
Labeler NameAscendis Pharma Endocrinology, Inc.
Substance NameLONAPEGSOMATROPIN
Active Ingredient Strength4 mg/1
Pharm ClassesHuman Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 73362-004-01

4 BLISTER PACK in 1 CARTON (73362-004-01) > 1 CARTRIDGE in 1 BLISTER PACK (73362-004-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE
Marketing Start Date2021-08-25
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Skytrofa" or generic name "Lonapegsomatropin-tcgd"

NDCBrand NameGeneric Name
73362-003SkytrofaLonapegsomatropin-tcgd
73362-004SkytrofaLonapegsomatropin-tcgd
73362-005SkytrofaLonapegsomatropin-tcgd
73362-006SkytrofaLonapegsomatropin-tcgd
73362-007SkytrofaLonapegsomatropin-tcgd
73362-008SkytrofaLonapegsomatropin-tcgd
73362-009SkytrofaLonapegsomatropin-tcgd
73362-010SkytrofaLonapegsomatropin-tcgd
73362-011SkytrofaLonapegsomatropin-tcgd

Trademark Results [Skytrofa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SKYTROFA
SKYTROFA
90154281 not registered Live/Pending
Ascendis Pharma Endocrinology Division A/S
2020-09-02
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.