Application 078329

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078329-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2009-02-05
A078329-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2009-02-05
A078329-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2009-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078329-001AB
A078329-002AB
A078329-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0584e616aacf4f…
2026-09-14 22:38:342026-08A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0584e616aacf4f…
2026-09-14 22:38:342026-08A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0584e616aacf4f…
2026-08-18 06:07:402026-07A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078329-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078329-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078329-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078329-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078329-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078329-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078329-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-001AB1301d65b070ca…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy88dd304f-1c64-08e3-e053-2a95a90a596f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY88dda062-2b9c-3632-e053-2a95a90a14312026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.60c731c6-4dc4-490a-8469-0b7e58e563a12026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENBryant Ranch Prepack1ebf94fb-76b6-4c01-be1b-5750628275452026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENBryant Ranch Prepack0550fa2f-f25e-4abb-b10e-a3d05bdb32172026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENBryant Ranch Prepackc38a03fa-6b9a-4737-a848-063ca5c580b92026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENStrides Pharma Science Limiteda266a3c6-932f-476f-ae93-48a785c922862025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.06710aef-2631-4925-8e9e-33bae84b59122025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC3b9fdc48-c071-4e2c-e063-6294a90a679f2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENAsclemed USA, Inc.d7ed42c4-371c-4a54-ab15-0630656f04272025-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsab11e142-9e11-4ce4-9671-7e4fe53ffe922025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsf1842893-7a34-4f77-8231-55fb0c98b22b2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3732defa-67c2-4b84-8a84-4bbc27b6cb242025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
ndc (product): 72789-186
ndc (product): 72789-187
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.689dbbe8-4f85-48fe-8efc-fda81b60d37f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
ndc (product): 72789-200
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.09621787-9a5c-4abf-9ccd-d6f8d581738f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
ndc (product): 72789-212
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.42b92fd7-468c-4fb8-9ff0-31296735df4c2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
ndc (product): 72789-201
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7942cc53-1268-4e5f-8db0-f0b3524bb7442025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
ndc (product): 72789-218
IbuprofenIBUPROFENProficient Rx LPc5eaa3a9-5aa8-46b0-8cec-639bfb3274752025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329

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 3 of 3 · 192 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72789-186IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-186IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-186IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-186IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-187IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-187IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-187IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-187IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-187IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-198IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-198IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-198IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-198IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-198IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-198IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-200IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-200IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-200IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-200IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-200IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-201IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-201IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-212IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-218IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-218IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23903ORIG2009-03-03