Application 075185

Type
ANDA
Sponsor
CARLSBAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL75MGNoNo
002DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL25MGNoNo
003DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL50MGNoNo

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
A075185-001DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-002DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-003DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075185-001AB
A075185-002AB
A075185-003AB

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 · 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 UTC2026-02A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-002DICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-003DICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075185-001DICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-138072bd15b7f6…

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 UTC2026-02A075185-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075185-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075185-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075185-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075185-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075185-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075185-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075185-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075185-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075185-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075185-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075185-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075185-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075185-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075185-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075185-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075185-001AB18072bd15b7f6…

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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.ddd2278b-70be-41ca-8a84-e3fe0f1a15612026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
ndc (product): 70518-2707
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.30c7e4fd-30af-4d28-a6ef-7386ff83cfb82026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
ndc (product): 70518-1104
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.10991fe6-fafd-49af-9684-83b447c19c672026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
ndc (product): 70518-0627
Diclofenac Sodium D/RDICLOFENAC SODIUM D/RDirectRx50886f90-8cd0-4d38-e063-6294a90a44e42026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.7e940ce5-0f82-4d07-b507-c644481879c12026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.e947653c-6789-4c15-82c9-4b1402f6d6ac2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
ndc (product): 68788-8952
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMRedpharm Drug4cd2e51b-2019-6eb6-e063-6294a90ad7ef2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions0cefb675-c54e-44eb-b35c-38354b77eddd2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions74011b00-7e2e-40a7-ab30-c05a205598142026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac SodiumDICLOFENAC SODIUMAvKARE19b4ff5c-adb7-a0d0-7ef2-4ae05047fd942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.14c1b1a1-bc06-4722-9612-e88ae52272bc2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
ndc (product): 70518-0756
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCc16e7e43-3869-9fef-e053-2995a90a1fdb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCf2b7ea75-738b-54a8-e053-2995a90a00d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC47a7a294-55bb-8d19-e063-6394a90a54402025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions40388047-7fbe-49bf-bed8-e5087bed4e032025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions4a88f136-f7c7-47d7-b85d-8a2f9f118f092025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions58063c26-86fe-4f03-97ef-51706e5f40542025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC4539e9e7-5d82-3b36-e063-6394a90a13962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLCb8072af2-9940-4827-9fbd-de46ad8bf9292025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075185
application number: ANDA075185

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 161 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67296-1197Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1197Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1197Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1805Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
67296-1805Diclofenac SodiumDiclofenac SodiumRedPharm Drug, Inc.ANDACurrent
68071-3184Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3184Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3184Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4117Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4117Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4117Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4231Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4231Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4934Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4934Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8952Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8952Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8952Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8952Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8952Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9806Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9806Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9806Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9806Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
69336-202Flexipakdiclofenac sodium, capsaicinSterling-Knight Pharmaceuticals, LLCANDACurrent
69621-093Xenaflammdiclofenac sodium, capsaicinShoreline Pharmaceuticals, Inc.ANDACurrent
70518-0627Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0627Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0627Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0627Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0627Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0627Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0756Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0756Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0756Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0756Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0756Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-1104Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-1104Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2707Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2707Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2707Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2707Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70882-128Diclofenac Sodium Delayed ReleaseDiclofenac SodiumCambridge Therapeutics Technologies, LLCANDACurrent
70934-122Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-122Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-122Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-157Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-157Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-157Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-165Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-165Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-165Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-678Diclofenac SodiumDiclofenac SodiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-494Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-494Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-991Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-991Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-991Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-991Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-995Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-995Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-995Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-995Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71335-0357Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0357Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0357Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0357Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0481Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0481Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0481Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
71335-0481Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
72275-731InavixDiclofenac Sodium, CapsaicinPrimary Pharmaceuticals, Inc.ANDACurrent
80425-0055VoltarenDiclofenac Sodium 75mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0055Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0055Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0055Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0189Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0189Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0189Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8555ORIG1998-11-13