Details for New Drug Application (NDA): 064126
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NDA 064126 describes ERYTHROMYCIN, which is a drug marketed by Arbor Pharms Llc, 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, Mylan, Amneal Pharms Co, Torrent, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus, Zydus Pharms, Lyne, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Par Pharm Inc, 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 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. One supplier is listed 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. One supplier is listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 064126
| Tradename: | ERYTHROMYCIN |
| Applicant: | Padagis Us |
| Ingredient: | erythromycin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 064126
| Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 064126
Suppliers and Packaging for NDA: 064126
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN | erythromycin | SWAB;TOPICAL | 064126 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-962 | 45802-962-72 | 60 APPLICATOR in 1 JAR (45802-962-72) / .8 mL in 1 APPLICATOR |
| ERYTHROMYCIN | erythromycin | SWAB;TOPICAL | 064126 | ANDA | Bryant Ranch Prepack | 63629-8648 | 63629-8648-1 | 60 APPLICATOR in 1 JAR (63629-8648-1) / .8 mL in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SWAB;TOPICAL | Strength | 2% | ||||
| Approval Date: | Jul 3, 1996 | TE: | AT | RLD: | No | ||||
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