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 | REMEDYREPACK INC. | 87db8bce-1b6f-4f1b-ab62-b3778c429b2e | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4f0ddf1a-eda6-8ca8-e063-6294a90a4102 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Aurobindo Pharma Limited | 2367340c-d297-4a3f-8253-6d27a0ed39cb | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 51dfa3fa-6f6a-4904-a8d3-b5938cf9c852 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | adf8f0fa-f794-4e97-a7b3-16b55d9c9a68 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | 8e66de7a-d9d4-4562-bc99-80489d482da4 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Cleocin | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | 3db26227-208d-4fdd-8426-1d9be5cda9b4 | 2026-03-09 | Warnings, Adverse reactions | Cleocin |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | bde81d4b-ad21-cc09-e053-2995a90a8c01 | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ba9bd5cd-036b-4b0c-e053-2a95a90a332e | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Sportpharm LLC | 3bddb5d2-ddac-2f03-e063-6294a90aa68c | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | ebdcd3ce-3140-4bf6-b8b8-468ead08d9a9 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | RedPharm Drug, Inc. | a2f6fa76-a114-4104-e053-2a95a90a9e0b | 2026-01-24 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Northwind Health Company, LLC | f2f08e98-f6c5-7c2d-e053-2995a90abe1e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Northwind Health Company, LLC | f781897a-ab54-7373-e053-6294a90a89a3 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Northwind Health Company, LLC | f6f5c8b2-83a1-5362-e053-6394a90aaaad | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4730ab20-09e2-d32a-e063-6394a90ae125 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Redpharm Drug | 0a0fbeae-2bc2-2402-e063-6394a90a97a0 | 2025-12-25 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Redpharm Drug | 3256c93b-f26c-aeb9-e063-6394a90ae9c2 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Cleocin | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | f9be442d-0782-4b93-828f-9ebbf67dbced | 2025-11-19 | Warnings, Adverse reactions | Cleocin |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | VERITYRX, LLC | 427a0138-c2dd-cf0b-e063-6394a90af407 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.