FDA.reportPublic FDA data

Application 213203

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL600MG;60MGNoNo
002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.2GM;120MGNoNo

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

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
A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25
A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213203-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2020-03-2587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213203-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2020-03-2587673890dc5c…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLAmerisource Bergen775000bc-56de-4c72-87da-65bb33f063b32024-12-03WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLAurohealth LLC2f622f57-4de0-44a9-a21f-c98260574f1e2024-09-03WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 58602-834
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLAurohealth LLC644dae51-7865-408c-a603-5eddffb90e532024-09-03WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 58602-833
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLWALGREEN CO.4c3b99f0-83af-4df0-a681-f2fc8778f8bb2024-04-20WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 0363-0134
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLMeijerc051be4b-88c9-e56f-e053-2995a90a3aa82023-12-01WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 79481-1002
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLKROGER COMPANYb97aeb2c-07ac-d00e-e053-2a95a90abf402023-12-01WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 30142-137
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLWALGREEN CO.cc1ac1b4-cbc4-539c-e053-2a95a90a5b752023-12-01WarningsExact identifier
application applno (ANDA): 213203
application number: ANDA213203
ndc (product): 0363-9946

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
0363-9946Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClWALGREEN CO.ANDACurrent
30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClKROGER COMPANYANDACurrent
30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClKROGER COMPANYANDACurrent
58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClAurohealth LLCANDACurrent
79481-1002Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HClMeijerANDACurrent