FDA.reportPublic FDA data

Application 021106

Type
BLA
Sponsor
PHARMACIA

Application Products#

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

NDC Listings For This Application#

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

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