FDA.reportPublic FDA data

Application 020280

Type
BLA
Sponsor
PHARMACIA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020280Genotropinsomatropin351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION0.2MG/VIALNoNo
002GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION0.4MG/VIALNoNo
003GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION0.6MG/VIALNoNo
004GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION1.5MG/VIALNoNo
005GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION0.8MG/VIALNoNo
006GENOTROPINSOMATROPININJECTABLE;INJECTION5.8MG/VIALNoNo
007GENOTROPINSOMATROPININJECTABLE;INJECTION13.8MG/VIALNoNo
008GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION1MG/VIALNoNo
009GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION1.2MG/VIALNoNo
010GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION1.4MG/VIALNoNo
011GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION1.6MG/VIALNoNo
012GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION1.8MG/VIALNoNo
013GENOTROPIN PRESERVATIVE FREESOMATROPININJECTABLE;INJECTION2MG/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
GENOTROPINSOMATROPINPfizer Laboratories Div Pfizer Incffebf88b-d257-4542-9808-74d9b71677652026-08-04Warnings, Adverse reactionsExact identifier
application number: BLA020280
ndc (product): 0013-2626
ndc (product): 0013-2649
ndc (product): 0013-2657
ndc (product): 0013-2654
ndc (product): 0013-2656
ndc (product): 0013-2646
ndc (product): 0013-2651
ndc (product): 0013-2653
ndc (product): 0013-2655
ndc (product): 0013-2650
ndc (product): 0013-2658
ndc (product): 0013-2652

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0013-2626GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2626GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2626GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2626GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2626GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2646GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2646GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2646GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2646GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2646GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2649GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2649GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2649GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2649GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2649GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2650GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2650GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2650GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2650GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2650GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2651GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2651GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2651GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2651GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2651GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2652GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2652GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2652GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2652GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2652GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2653GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2653GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2653GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2653GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2653GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2654GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2654GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2654GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2654GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2654GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2655GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2655GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2655GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2655GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2655GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2656GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2656GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2656GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2656GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2656GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2657GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2657GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2657GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2657GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2657GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent
0013-2658GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2658GENOTROPINsomatropinPharmacia and Upjohn Company LLCNDACurrent
0013-2658GENOTROPINsomatropinPharmacia and Upjohn CompNDACurrent
0013-2658GENOTROPINsomatropinPharmacia and Upjohn Company LLCBLACurrent
0013-2658GENOTROPINsomatropinPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82785SUPPL 2025-07-11
82772SUPPL 2025-07-11
79445SUPPL 2024-08-20
79433SUPPL 2024-08-19
66365SUPPL2021-02-25
61543SUPPL2020-03-23
61541SUPPL2020-03-23
46181SUPPL2020-03-23
46154SUPPL2020-03-23
45274SUPPL2020-03-23
45243SUPPL2020-03-23
41265SUPPL2020-03-23
41264SUPPL2020-03-23
34468SUPPL2020-03-23
34467SUPPL2020-03-23
34466SUPPL2020-03-23
34465SUPPL2020-03-23
34464SUPPL2020-03-23
34463SUPPL2020-03-23
34462SUPPL2020-03-23
24726SUPPL2020-03-23
24725SUPPL2020-03-23
24724SUPPL2020-03-23
24723SUPPL2020-03-23
24722SUPPL2020-03-23
24721SUPPL2020-03-23
24720SUPPL2020-03-23
24719SUPPL2020-03-23
24718SUPPL2020-03-23
24717SUPPL2020-03-23
24716SUPPL2020-03-23
24175SUPPL2020-03-23
20583SUPPL2020-03-23
12418SUPPL2020-03-23
12417SUPPL2020-03-23
12416SUPPL2020-03-23
12415SUPPL2020-03-23
12414SUPPL2020-03-23
12413SUPPL2020-03-23
12412SUPPL2020-03-23
2292SUPPL2020-03-23
2291SUPPL2020-03-23
2290SUPPL2020-03-23
2289SUPPL2020-03-23
2288SUPPL2020-03-23
2287SUPPL2020-03-23