Application 061809
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLEOCIN | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 002 | CLEOCIN | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061809-001 | CLEOCIN | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | ||
| A061809-002 | CLEOCIN | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 678912ff-a0c1-171b-e053-2991aa0ad128 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 63f26644-b7ab-98c1-e053-2a91aa0af5d3 | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 2393251d-33b9-4274-9d04-27ec9968eaa1 | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Chartwell RX, LLC | e8167412-882e-4143-93c6-49e68adbcf16 | 2024-01-17 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | AvPAK | b2a810f1-c009-e973-e053-2a95a90ad5b0 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 337870c6-11e0-4d1a-a26e-afe042ee08c3 | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | e08eea9e-464c-429e-9584-b768f5127767 | 2023-12-29 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 600c5ac7-64f7-44ac-9e83-cc1036471eec | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 22bf9385-cad3-43a7-802f-131b6826b5a5 | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Asclemed USA, Inc. | cd5a1db8-9ddf-4de3-b856-bc3e8fb29061 | 2023-05-02 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 07f5d841-9c58-4dd1-b0bc-e12553931c8e | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 18ef4551-4066-4765-90cb-285d7711cf61 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Proficient Rx LP | f7e51a42-bc9e-490f-b8d8-8765f0b5be46 | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Proficient Rx LP | 158e6c0c-1ca3-49a6-84fd-54d8fde7c2a7 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Proficient Rx LP | d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.