Home Applications 021773 Application 021773
Type NDA
Sponsor ASTRAZENECA AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BYETTA EXENATIDE SYNTHETIC INJECTABLE;SUBCUTANEOUS 300MCG/1.2ML (250MCG/ML) Yes Yes 002 BYETTA EXENATIDE SYNTHETIC INJECTABLE;SUBCUTANEOUS 600MCG/2.4ML (250MCG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021773-001 BYETTA EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28 N021773-002 BYETTA EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD 2005-04-28
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 2 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021773-001 BYETTA 300MCG/1.2ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021773-002 BYETTA 600MCG/2.4ML (250MCG/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2005-04-28 3a93d1ddd44b…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021773-001 AP 1 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021773-002 AP 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021773-001 AP 1 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021773-002 AP 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021773-001 AP 1 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021773-002 AP 1 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021773-001 AP 1 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021773-002 AP 1 2680178bc6a6…
Observed Orange Book patent history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
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.
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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6512 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current 0310-6524 Byetta exenatide AstraZeneca Pharmaceuticals LP NDA Current