Application 208864

Type
ANDA
Sponsor
ADARE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL8MEQNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MEQNoNo

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
A208864-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17
A208864-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A208864-001AB
A208864-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208864-001POTASSIUM CHLORIDE8MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A208864-002POTASSIUM CHLORIDE10MEQCAPSULE, EXTENDED RELEASE / ORALAB2017-03-17782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208864-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208864-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208864-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208864-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208864-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208864-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208864-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208864-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208864-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208864-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208864-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208864-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208864-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208864-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208864-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208864-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208864-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208864-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208864-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208864-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208864-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208864-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208864-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208864-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208864-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208864-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208864-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208864-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208864-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208864-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208864-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208864-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208864-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208864-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208864-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208864-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208864-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208864-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208864-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208864-002AB1782e0a99824c…

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
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.018fc687-1fba-202e-e063-6294a90a5c9a2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 72789-057
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.cc15ef60-6956-4d34-b86d-72cdd0c0c0bb2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 72789-056
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ccaaa3a2-a273-41c7-9e54-429539ea01402024-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 72789-057
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health Packaging96ea00f5-b922-4d57-b2ac-34523ea56d5f2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 60687-653
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepack65e30d1a-50e9-4b84-ad4d-daaea91eab4b2024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 72162-1076
POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.4d90d03d-7f0e-4d49-9e80-628dbc7165c02024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 63304-078
ndc (product): 63304-090
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAdare Pharmaceuticals Inc22edb0e6-4e45-4e91-aead-3581cca293a02023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208864
application number: ANDA208864
ndc (product): 59917-102
ndc (product): 59917-103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-977POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-977POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-977POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-977POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-978POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-978POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-978POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
59917-102POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdare Pharmaceuticals IncANDACurrent
59917-102POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdare Pharmaceuticals IncANDACurrent
59917-102POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdare Pharmaceuticals IncANDACurrent
59917-103POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdare Pharmaceuticals IncANDACurrent
59917-103POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdare Pharmaceuticals IncANDACurrent
59917-103POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdare Pharmaceuticals IncANDACurrent
60687-653POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health PackagingANDACurrent
60687-653POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAmerican Health PackagingANDACurrent
63304-078POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
63304-090POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
63629-1076POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1076POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1076POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1076POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1077POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1077POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1077POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1077POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1078POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1078POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1078POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1078POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1079POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1079POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1079POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1079POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1080POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1080POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1080POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
63629-1080POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
70518-3384POTASSIUM CHLORIDEPOTASSIUM CHLORIDEREMEDYREPACK INC.ANDACurrent
72162-1076POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
72162-1076POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch PrepackANDACurrent
72789-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-056POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-056POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-056POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-057POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-057POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-057POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-057POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent