Details for New Drug Application (NDA): 215661
✉ Email this page to a colleague
NDA 215661 describes ERYTHROMYCIN, which is a drug marketed by Barr, Carnegie, Encube, Fougera Pharms, Padagis Us, Elkins Sinn, Bausch And Lomb, Pharmaderm, Pharmafair, Sentiss, Paddock Llc, Alpharma Us Pharms, Bausch, Lilly, Pai Holdings Pharm, Pharmobedient Cnsltg, Renaissance Pharma, Epic Pharma Llc, Norvium Bioscience, Amneal Pharms Co, Torrent, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus Lifesciences, Zydus Pharms, Rising, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Endo Operations, Dista, Naska, Parke Davis, Aurobindo Pharma Usa, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Gland Pharma Ltd, Nexus, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the ERYTHROMYCIN profile page.
The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.
The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 215661
| Tradename: | ERYTHROMYCIN |
| Applicant: | Alembic |
| Ingredient: | erythromycin |
| Patents: | 0 |
Pharmacology for NDA: 215661
| Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 215661
Suppliers and Packaging for NDA: 215661
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN | erythromycin | TABLET;ORAL | 215661 | ANDA | Alembic Pharmaceuticals Limited | 46708-397 | 46708-397-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-397-30) |
| ERYTHROMYCIN | erythromycin | TABLET;ORAL | 215661 | ANDA | Alembic Pharmaceuticals Limited | 46708-397 | 46708-397-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-397-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Aug 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 24, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
