Details for New Drug Application (NDA): 216066
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NDA 216066 describes ERYTHROMYCIN, which is a drug marketed by Azurity, Barr, 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, Lyne, 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, Nexus, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy-six 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 216066
| Tradename: | ERYTHROMYCIN |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | erythromycin |
| Patents: | 0 |
Pharmacology for NDA: 216066
| Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 216066
Suppliers and Packaging for NDA: 216066
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN | erythromycin | TABLET;ORAL | 216066 | ANDA | Ascend Laboratories, LLC | 67877-762 | 67877-762-01 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-762-01) |
| ERYTHROMYCIN | erythromycin | TABLET;ORAL | 216066 | ANDA | Ascend Laboratories, LLC | 67877-762 | 67877-762-05 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-762-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 13, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 13, 2022 | TE: | AB | RLD: | No | ||||
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