FDA.reportPublic FDA data

Application 075682

Type
ANDA
Sponsor
DR REDDYS LA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075682-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2001-11-14
A075682-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2001-11-14
A075682-003IBUPROFENIBUPROFEN800MGTABLET / ORALABRS2001-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075682-001AB
A075682-002AB
A075682-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14c2088c7a36db…
2026-10-15 13:18:302026-09A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14c2088c7a36db…
2026-10-15 13:18:302026-09A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14c2088c7a36db…
2026-09-14 22:38:342026-08A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-1484e616aacf4f…
2026-08-18 06:07:402026-07A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A075682-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075682-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075682-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A075682-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075682-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075682-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075682-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075682-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075682-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075682-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075682-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075682-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-001AB179d66fd596c7…

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLCffec2f44-1144-4729-b43a-1db40ea6a8d32019-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682

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 2 of 3 · 185 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61919-621IBUIBUDirect _RxANDACurrent
61919-621IBUIBUDirect_RxANDACurrent
61919-621IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-621IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-621IBUPROFENIBUPROFENDirect_RxANDACurrent
61919-960IBUPROFENIBUPROFENDirectRXANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
61919-960ibuprofenibuprofenDirect_RxANDACurrent
63187-614IBUIbuprofenProficient Rx LPANDACurrent
63187-614IBUIbuprofenProficient Rx LPANDACurrent
63187-614IBUIbuprofenProficient Rx LPANDACurrent
63187-614IBUIbuprofenProficient Rx LPANDACurrent
63187-614IBUIbuprofenProficient Rx LPANDACurrent
63629-1468IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-1468IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
63629-6519IBUPROFENIbuprofenBryant Ranch PrepackANDACurrent
63629-6519IBUPROFENIbuprofenBryant Ranch PrepackANDACurrent
63629-6520IBUPROFENIbuprofenBryant Ranch PrepackANDACurrent
63629-6520IBUPROFENIbuprofenBryant Ranch PrepackANDACurrent
66267-116IBUIbuprofenNuCare Pharmaceuticals, IANDACurrent
66267-116IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-116IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-117IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-117IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-793IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-793IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-794IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-794IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-795IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-795IBUIbuprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-963IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-963IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-963IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-964IBUIbuprofenNuCare Pharmaceuticals Inc.ANDACurrent
66267-964IBUIbuprofenNuCare Pharmaceuticals Inc.ANDACurrent
66267-964IBUIbuprofenNuCare Pharmaceuticals Inc.ANDACurrent
67046-300IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-308IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-309IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-310IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-311IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-312IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67296-0877IBUIBURedPharm Drug, Inc.ANDACurrent
67296-0877IBUIBURedPharm Drug, Inc.ANDACurrent
67296-0877IBUIBURedPharm Drug, Inc.ANDACurrent
67296-0913IBUIBURedPharm Drug, Inc.ANDACurrent
67296-0913IBUIBURedPharm Drug, Inc.ANDACurrent
67296-0913IBUIBURedPharm Drug, Inc.ANDACurrent
67296-1217IBUIBURedPharm Drug, Inc.ANDACurrent
67296-1217IBUIBURedPharm Drug, Inc.ANDACurrent
67296-1217IBUIBURedPharm Drug, Inc.ANDACurrent
67296-1717IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1717IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
68071-1827IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3053IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3053IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3125IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3125IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3125IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3172IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3172IBUIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9110IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9110IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9110IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9110IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9110IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9111IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9111IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9111IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9111IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9111IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9112IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9112IbuprofenIbuprofenPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22495ORIG2005-07-22
8763ORIG2003-04-14