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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A061809-001 | CLEOCIN | EQ 75MG BASE | CAPSULE / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A061809-002 | CLEOCIN | EQ 150MG BASE | CAPSULE / ORAL | Approved before 1982 | 782e0a99824c… |
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 | HAWAII REPACK, INC. | c6703df0-b41d-439f-8e0d-d30b3039b3f8 | 2026-07-18 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 1dd9e6b0-bcf4-5bf4-e063-6394a90a10c2 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | REMEDYREPACK INC. | f4c4fce0-0472-45a3-b4c6-192d97ca1818 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Major Pharmaceuticals | d53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef5 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 8e3c9cf6-ab39-4fb5-94e3-232880c47700 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | de7001d1-8b83-4f8b-8e50-c07691021456 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | fadc321a-2291-4268-936f-0743fdddbe7f | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Major Pharmaceuticals | f9e6ed50-ad03-4a9e-8760-8733e04a058c | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 1dbd8448-c1e5-46df-8060-50ef82380445 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 47f76d99-2024-4531-a527-66c80deeeb37 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 5f6a85c5-dca3-49b1-a029-3818a41d49bf | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 1f1b9230-b8ef-b0e4-e063-6394a90afc47 | 2026-06-07 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 535e7e17-d020-4aa6-e063-6294a90ae114 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | afeb96ed-7c2e-72d3-e053-2995a90a4ed3 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | a69260bb-31b5-4f77-e053-2995a90a37e1 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | REMEDYREPACK INC. | 7f7fc73a-86e1-4d3e-8c83-1c74621e4af4 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | e4d91d51-b92e-4d3e-8379-f9463f450537 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Proficient Rx LP | d1aa1e91-4ac8-40d1-9fc4-963e1c9c3278 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Coupler LLC | 509a9bc3-0901-0874-e063-6294a90a8816 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |
| clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN HYDROCHLORIDE |