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)Disc2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-d257-4542-9808-74d9b71677652026-04-30Warnings, 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