Application 020929

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION0.25MG/2MLYesNo
002PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION0.5MG/2MLYesNo
003PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION1MG/2MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020929-001PULMICORT RESPULESBUDESONIDE0.25MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08
N020929-002PULMICORT RESPULESBUDESONIDE0.5MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08
N020929-003PULMICORT RESPULESBUDESONIDE1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020929-001AN
N020929-002AN
N020929-003AN

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-002PULMICORT RESPULES0.5MG/2MLSUSPENSION / INHALATIONANRLD2000-08-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-003PULMICORT RESPULES1MG/2MLSUSPENSION / INHALATIONANRLD, RS2000-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020929-001PULMICORT RESPULES0.25MG/2MLSUSPENSION / INHALATIONANRLD2000-08-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020929-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-002AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020929-003AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-002AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020929-003AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020929-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-002AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020929-003AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-002AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020929-003AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-002AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020929-003AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-002AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020929-003AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-002AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020929-003AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-002AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020929-003AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-002AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020929-003AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020929-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-002AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020929-003AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-002AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020929-003AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-002AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020929-003AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-001AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-002AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020929-003AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020929-001AN18072bd15b7f6…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020929-0017524834*PED2019-05-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0016598603*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0016899099*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0027524834*PED2019-05-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0026598603*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0026899099*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0037524834*PED2019-05-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0036598603*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020929-0036899099*PED2019-06-23Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020929-0017524834*PED2019-05-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0016598603*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0016899099*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0027524834*PED2019-05-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0026598603*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0026899099*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0037524834*PED2019-05-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0036598603*PED2019-06-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020929-0036899099*PED2019-06-23Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020929-0017524834*PED2019-05-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0016598603*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0016899099*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0027524834*PED2019-05-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0026598603*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0026899099*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0037524834*PED2019-05-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0036598603*PED2019-06-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020929-0036899099*PED2019-06-23Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020929-0017524834*PED2019-05-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0016598603*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0016899099*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0027524834*PED2019-05-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0026598603*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0026899099*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0037524834*PED2019-05-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0036598603*PED2019-06-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020929-0036899099*PED2019-06-23Pediatric extensionea99ee380514…

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
PULMICORT RESPULESBUDESONIDEAstraZeneca Pharmaceuticals LP33cd9834-76df-4f26-3fa2-aab6b9eee8f22019-10-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020929
application number: NDA020929
ndc (product): 0186-1988
ndc (product): 0186-1990
ndc (product): 0186-1989

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59950SUPPL2019-09-10
59937SUPPL2019-09-09
26216SUPPL2010-07-23
13753SUPPL2010-07-06
3767SUPPL2009-11-10
13752SUPPL2009-10-14
26215SUPPL2007-07-05
41817SUPPL2007-04-11
21280SUPPL2007-04-11
3764SUPPL2006-07-21
3766SUPPL2005-07-08
21279ORIG2004-02-11
13751SUPPL2003-09-30
26214SUPPL2003-09-26
26213SUPPL2003-03-10
35656SUPPL2003-02-26
3765SUPPL2003-01-10
35655ORIG2000-08-08
26212ORIG2000-08-08
51795ORIG1900-01-01
51794ORIG1900-01-01
51793ORIG1900-01-01
51792ORIG1900-01-01
51791ORIG1900-01-01
51790ORIG1900-01-01
51789ORIG1900-01-01