Application 062803

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCIN PHOSPHATECLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 150MG BASE/MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062803-001CLEOCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062803-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-163f01610625f2…
2019-09-15 20:21 UTC2019-09A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062803-001CLEOCIN PHOSPHATEEQ 150MG BASE/MLINJECTABLE / INJECTIONAP1987-10-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062803-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062803-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062803-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062803-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062803-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062803-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062803-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062803-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062803-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062803-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062803-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062803-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062803-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062803-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062803-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062803-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062803-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062803-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062803-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062803-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062803-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A062803-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062803-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062803-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062803-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A062803-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062803-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062803-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062803-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062803-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062803-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062803-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062803-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062803-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062803-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062803-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062803-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062803-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062803-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062803-001AP1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cleocin PhosphateCLINDAMYCIN PHOSPHATEPharmacia & Upjohn Company LLC05a75685-0af5-407c-ac57-e380c882b49d2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0009-3124
ndc (product): 0009-6582
ndc (product): 0009-3447

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-3124Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3124Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3124Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3124Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3124Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3124Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3447Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3447Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3447Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3447Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3447Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-3447Cleocin Phosphateclindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-6582Cleocin Phosphate (0009-6582) (Standalone)clindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-6582Cleocin Phosphate (0009-6582) (Standalone)clindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-6582Cleocin Phosphate (0009-6582) (Standalone)clindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-6582Cleocin Phosphate (0009-6582) (Standalone)clindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-6582Cleocin Phosphate (0009-6582) (Standalone)clindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
0009-6582Cleocin Phosphate (0009-6582) (Standalone)clindamycin phosphatePharmacia and Upjohn Company LLCANDACurrent
47781-619Clindamycin Phosphateclindamycin phosphateAlvogen, Inc.ANDACurrent
47781-619Clindamycin Phosphateclindamycin phosphateAlvogen, Inc.ANDACurrent
47781-620Clindamycin Phosphateclindamycin phosphateAlvogen, Inc.ANDACurrent
47781-620Clindamycin Phosphateclindamycin phosphateAlvogen, Inc.ANDACurrent
47781-621Clindamycin Phosphateclindamycin phosphateAlvogen, Inc.ANDACurrent
47781-621Clindamycin Phosphateclindamycin phosphateAlvogen, Inc.ANDACurrent
72611-634Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-634Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-639Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-639Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-642Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-642Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-645Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent
72611-645Clindamycin Phosphateclindamycin phosphateALMAJECT, INC.ANDACurrent