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 | A-S Medication Solutions | 09eea0ad-702f-4eea-bfb9-81effc76b22b | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 9fe68a5a-487b-4119-9ee7-603948d732e4 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | cd2ca915-5672-440d-a14e-b4d3b6a522f3 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | c3f35f80-e4ae-95f5-e053-2995a90a1b64 | 2025-07-25 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | American Health Packaging | 3f6b2c5a-e581-414f-bc9e-eaf66a5685cd | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 12dea490-e179-f295-e063-6394a90af4aa | 2025-04-25 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Brisk Pharmaceuticals | 2de041be-1d36-ee95-e063-6294a90a2091 | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 2178249b-a9fe-5015-e063-6294a90a9ff4 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Quality Care Products, LLC | 1d562ae9-5a9a-4fed-8cc7-3f30fb40f957 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 7b110bab-815e-4654-860b-b9142fd93d45 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 2290109b-45c9-1aab-e063-6294a90a673b | 2024-09-20 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 2b13d66d-4f48-477e-ba32-20e85d0e708d | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 7537fbab-c792-4b77-8736-c24b69cf48ea | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 8af1493c-1f22-4629-a432-f8b0578189e1 | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 11e8dd9c-81fd-4e88-e063-6294a90af13e | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | bea7de4c-c077-4535-96a0-f6b319120b0b | 2024-08-07 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | b2bd8402-c887-5bfd-e053-2a95a90a15d9 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 1d760cb7-d166-6707-e063-6394a90a8850 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9e68cb17-73d9-8a00-e053-2995a90a517f | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9fe44bdd-eb59-4b55-e053-2995a90a3183 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.