Application 216957
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 003 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216957-001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | |
| A216957-002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | |
| A216957-003 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216957-001 | AB |
| A216957-002 | AB |
| A216957-003 | AB |
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 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216957-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216957-003 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216957-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2023-03-10 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216957-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216957-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216957-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216957-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216957-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216957-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216957-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216957-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216957-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216957-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216957-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216957-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216957-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216957-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216957-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216957-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216957-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216957-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216957-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216957-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216957-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216957-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216957-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216957-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216957-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216957-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216957-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216957-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216957-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216957-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216957-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216957-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216957-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216957-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216957-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216957-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216957-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216957-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216957-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216957-001 | AB | 1 | 8072bd15b7f6… |
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 | St. Mary's Medical Park Pharmacy | 1dd9e6b0-bcf4-5bf4-e063-6394a90a10c2 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 47f76d99-2024-4531-a527-66c80deeeb37 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 1f1b9230-b8ef-b0e4-e063-6394a90afc47 | 2026-06-07 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | e4d91d51-b92e-4d3e-8379-f9463f450537 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Proficient Rx LP | d1aa1e91-4ac8-40d1-9fc4-963e1c9c3278 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Coupler LLC | 509a9bc3-0901-0874-e063-6294a90a8816 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | REMEDYREPACK INC. | 87db8bce-1b6f-4f1b-ab62-b3778c429b2e | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4f0ddf1a-eda6-8ca8-e063-6294a90a4102 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 51dfa3fa-6f6a-4904-a8d3-b5938cf9c852 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | adf8f0fa-f794-4e97-a7b3-16b55d9c9a68 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | 8e66de7a-d9d4-4562-bc99-80489d482da4 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Sportpharm LLC | 3bddb5d2-ddac-2f03-e063-6294a90aa68c | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | ebdcd3ce-3140-4bf6-b8b8-468ead08d9a9 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Redpharm Drug | 3256c93b-f26c-aeb9-e063-6394a90ae9c2 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 09eea0ad-702f-4eea-bfb9-81effc76b22b | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | REMEDYREPACK INC. | fa084aad-07fa-44d2-8d01-d32f40acd2f3 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 12dea490-e179-f295-e063-6394a90af4aa | 2025-04-25 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Brisk Pharmaceuticals | 2de041be-1d36-ee95-e063-6294a90a2091 | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 2178249b-a9fe-5015-e063-6294a90a9ff4 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 7b110bab-815e-4654-860b-b9142fd93d45 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 216957 ANDA216957 |