FDA.reportPublic FDA data

Application 021106

Type
BLA
Sponsor
PHARMACIA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021106Somavertpegvisomant351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOMAVERTPEGVISOMANTINJECTABLE;SUBCUTANEOUS10MG/VIALNoNo
002SOMAVERTPEGVISOMANTINJECTABLE;SUBCUTANEOUS15MG/VIALNoNo
003SOMAVERTPEGVISOMANTINJECTABLE;SUBCUTANEOUS20MG/VIALNoNo
004SOMAVERTPEGVISOMANTINJECTABLE;SUBCUTANEOUS25MG/VIALNoNo
005SOMAVERTPEGVISOMANTINJECTABLE;SUBCUTANEOUS30MG/VIALNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOMAVERTPEGVISOMANTPharmacia & Upjohn Company LLC3cbb485b-6df1-49ce-8747-592b395b19882025-12-18Warnings, Adverse reactionsExact identifier
application number: BLA021106
ndc (product): 0009-7199
ndc (product): 0009-7168
ndc (product): 0009-7188
ndc (product): 0009-7200
ndc (product): 0009-7166

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5176SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5176SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5176SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-5176SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5176SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5178SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5178SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5178SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5180SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5180SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5180SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-5180SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5180SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-5200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7166SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-7166SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7166SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7166SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7166SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7166SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7166SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7168SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-7168SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7168SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7168SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7168SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7168SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7168SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7188SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-7188SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7188SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7188SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7188SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7188SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7188SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-7199SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7199SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7199SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7199SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCBLACurrent
0009-7200SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7200SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent
0009-7200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7200SOMAVERTpegvisomantPharmacia and Upjohn Company LLCNDACurrent
0009-7200SOMAVERTpegvisomantPharmacia & Upjohn Company LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74923SUPPL 2023-07-31
74914SUPPL 2023-07-28
68442SUPPL2021-08-23
68439SUPPL2021-08-22
68438SUPPL2021-08-22
68330SUPPL2021-08-10
66397APPL2020-03-23
60065SUPPL2020-03-23
60063SUPPL2020-03-23
59788SUPPL2020-03-23
59754SUPPL2020-03-23
36118SUPPL2020-03-23
36117SUPPL2020-03-23
36116SUPPL2020-03-23
36115ORIG2020-03-23
26768SUPPL2020-03-23
26767SUPPL2020-03-23
26766ORIG2020-03-23
21452ORIG2020-03-23
14388SUPPL2020-03-23
4333SUPPL2020-03-23