Application 021773

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BYETTAEXENATIDE SYNTHETICINJECTABLE;SUBCUTANEOUS300MCG/1.2ML (250MCG/ML)YesYes
002BYETTAEXENATIDE SYNTHETICINJECTABLE;SUBCUTANEOUS600MCG/2.4ML (250MCG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021773-001BYETTAEXENATIDE SYNTHETIC300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-28
N021773-002BYETTAEXENATIDE SYNTHETIC600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD2005-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2005-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021773-001BYETTA300MCG/1.2ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021773-002BYETTA600MCG/2.4ML (250MCG/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2005-04-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021773-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021773-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021773-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021773-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021773-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021773-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021773-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021773-002AP12680178bc6a6…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021773-00168727002020-01-14U-65474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021773-00169027442020-01-14Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021773-00268727002020-01-14U-65474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021773-00269027442020-01-14Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021773-00168727002020-01-14U-6548869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021773-00169027442020-01-14Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021773-00268727002020-01-14U-6548869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021773-00269027442020-01-14Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021773-00168727002020-01-14U-654c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021773-00169027442020-01-14Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021773-00268727002020-01-14U-654c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021773-00269027442020-01-14Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021773-00168727002020-01-14U-6543f01610625f2…
2019-12-14 00:12 UTC2019-12N021773-00169027442020-01-14Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021773-00268727002020-01-14U-6543f01610625f2…
2019-12-14 00:12 UTC2019-12N021773-00269027442020-01-14Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021773-00168727002020-01-14U-654b00525d2431f…
2019-09-15 20:21 UTC2019-09N021773-00169027442020-01-14Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021773-00268727002020-01-14U-654b00525d2431f…
2019-09-15 20:21 UTC2019-09N021773-00269027442020-01-14Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021773-00168727002020-01-14U-654ea99ee380514…
2019-07-19 19:46 UTC2019-07N021773-00169027442020-01-14Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021773-00268727002020-01-14U-654ea99ee380514…
2019-07-19 19:46 UTC2019-07N021773-00269027442020-01-14Drug productea99ee380514…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021773-001M-2322024-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021773-002M-2322024-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021773-001M-2322024-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021773-002M-2322024-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021773-001M-2322024-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021773-002M-2322024-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021773-001M-2322024-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021773-002M-2322024-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021773-001M-2322024-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N021773-002M-2322024-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021773-001M-2322024-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021773-002M-2322024-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021773-001M-2322024-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021773-002M-2322024-11-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021773-001M-2322024-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021773-002M-2322024-11-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021773-001M-2322024-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021773-002M-2322024-11-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021773-001M-2322024-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021773-002M-2322024-11-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021773-001M-2322024-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021773-002M-2322024-11-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021773-001M-2322024-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021773-002M-2322024-11-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021773-001M-2322024-11-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021773-002M-2322024-11-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021773-001M-2322024-11-04782e0a99824c…
2021-12-28 21:50 UTC2021-12N021773-002M-2322024-11-04782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021773-001M-2322024-11-046a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021773-002M-2322024-11-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021773-001M-2322024-11-041c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021773-002M-2322024-11-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021773-001M-2322024-11-04ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021773-002M-2322024-11-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021773-001M-2322024-11-04a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021773-002M-2322024-11-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021773-001M-2322024-11-049b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021773-002M-2322024-11-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021773-001M-2322024-11-04a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021773-002M-2322024-11-04a67488948f0b…

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
ByettaEXENATIDEAstraZeneca Pharmaceuticals LP53d03c03-ebf7-418d-88a8-533eabd2ee4f2025-09-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021773
application number: NDA021773
ndc (product): 0310-6524
ndc (product): 0310-6512

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6512ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent
0310-6524ByettaexenatideAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83277SUPPL 2025-09-03
83276SUPPL 2025-09-03
82382SUPPL 2025-06-02
82381SUPPL 2025-06-02
82342SUPPL 2025-05-29
80118SUPPL 2024-11-05
80109SUPPL 2024-11-04
73016SUPPL2022-12-23
73015SUPPL2022-12-23
72992SUPPL2022-12-22
71295SUPPL2022-06-14
71294SUPPL2022-06-14
71283SUPPL2022-06-13
71282SUPPL2022-06-13
69264SUPPL2021-11-05
69259SUPPL2021-11-05
69258SUPPL2021-11-05
67857SUPPL2021-06-22
67856SUPPL2021-06-22
67850SUPPL2021-06-22
62012SUPPL2020-03-03
62002SUPPL2020-03-02
62001SUPPL2020-03-02
56971SUPPL2018-12-21
56970SUPPL2018-12-21
37617SUPPL2015-03-03
28570SUPPL2015-02-27
16346SUPPL2014-11-26
6152SUPPL2014-11-26
16345SUPPL2011-11-04
16344SUPPL2011-11-04
28569SUPPL2011-10-24
6150SUPPL2011-10-24
6151SUPPL2011-08-10
28568SUPPL2010-11-18
37616SUPPL2010-11-17
28567SUPPL2010-08-20
43778ORIG2009-11-18
28566SUPPL2009-11-18
28565SUPPL2009-11-18
28564SUPPL2009-11-18
6149SUPPL2009-11-18
6148SUPPL2009-11-18
6147SUPPL2009-11-18
37615SUPPL2009-11-04
37613SUPPL2009-11-04
16343SUPPL2009-11-04
16342SUPPL2009-11-04
16341SUPPL2009-11-04
16339SUPPL2009-11-04
44151ORIG2009-11-02
28562SUPPL2008-06-20
16340SUPPL2008-06-19
28563SUPPL2008-01-18
37614SUPPL2008-01-15
6146SUPPL2007-02-23
37612SUPPL2007-02-16
28561SUPPL2007-01-08
6145SUPPL2007-01-08
37611SUPPL2006-12-28
16336SUPPL2006-12-28
28560SUPPL2006-11-06
16338SUPPL2006-11-06
28559SUPPL2006-10-18
16337SUPPL2006-10-13
42305ORIG2005-08-04
37610ORIG2005-05-03
28558ORIG2005-05-03