Application 062508
- Type
- ANDA
- Sponsor
- MERZ PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ERYMAX | ERYTHROMYCIN | SOLUTION;TOPICAL | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062508-002 | ERYMAX | ERYTHROMYCIN | 2% | SOLUTION / TOPICAL | 1985-07-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A062508-002 | ERYMAX | 2% | SOLUTION / TOPICAL | 1985-07-11 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Erythromycin | ERYTHROMYCIN | Sportpharm LLC | 790d3e3e-df69-45f7-97d5-da65faa46556 | 2026-07-21 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 50c8d6b3-4660-e829-e063-6294a90a919b | 2026-05-01 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Cardinal Health 107, LLC | ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5 | 2026-04-27 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Golden State Medical Supply, Inc. | 0c05e1f7-a3d4-8e69-e063-6394a90aecc3 | 2026-04-21 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Preferred Pharmaceuticals, Inc. | ee3d806e-65ce-42e1-b170-7b35bcb7b06a | 2026-04-10 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Sentiss Pharmaceuticals LLC | 4da0e351-383f-55da-e063-6394a90a8eba | 2026-03-31 | Adverse reactions | ERYTHROMYCIN |
| ERYTHROMYCIN | ERYTHROMYCIN | Direct Rx | 9ac4dcd2-8cac-404d-b651-da74062d30ed | 2026-03-17 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | 933049f6-61b9-4ed5-b6b7-60c5037e2115 | 2026-03-05 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | REMEDYREPACK INC. | c49ad63b-c2fd-4535-bec0-6415c93cf847 | 2026-01-09 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Redpharm Drug | 301ee5ad-3b6c-1152-e063-6294a90a54e7 | 2025-12-23 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | A-S Medication Solutions | 2be16639-b153-407b-b43d-3a2bcf66151e | 2025-12-03 | Adverse reactions | ERYTHROMYCIN |
| Ery | ERYTHROMYCIN | Padagis Israel Pharmaceuticals Ltd | 9a63da11-01be-4c63-a260-e6bdbb4a7a69 | 2025-10-31 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | PD-Rx Pharmaceuticals, Inc. | e54d66fa-93bb-4339-a75e-194a2e4488aa | 2025-10-20 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Bryant Ranch Prepack | 10ad1391-32fc-40c0-96d0-675f3c91429f | 2025-10-20 | Warnings, Adverse reactions | ERYTHROMYCIN |
| ERYTHROMYCIN | ERYTHROMYCIN | Ascend Laboratories, LLC | 3b415e31-e5d4-4990-8021-78459af73372 | 2025-10-17 | Warnings, Adverse reactions | ERYTHROMYCIN |
| erythromycin | ERYTHROMYCIN | Dr. Reddy's Labratories Inc. | a2dcb48a-212c-1b0c-ec35-ee2ade85847f | 2025-09-25 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | A-S Medication Solutions | 99eb7dbc-6ba9-4122-ad1e-5cae73186932 | 2025-05-02 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN | Amneal Pharmaceuticals NY LLC | 581d7430-1a80-42a6-befb-4c3ae8140392 | 2025-04-25 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Bausch & Lomb Incorporated | 061ddd20-94a6-4e3c-ba84-1ebd8529eea6 | 2025-04-22 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | ST. MARY'S MEDICAL PARK PHARMACY | 2cc726c2-3746-6dbf-e063-6294a90a789f | 2025-01-28 | Adverse reactions | ERYTHROMYCIN |