Details for New Drug Application (NDA): 050536
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NDA 050536 describes ERYC, which is a drug marketed by Dr Reddys Labs Sa, Parke Davis, Warner Chilcott Llc, Hospira, and Johnson And Johnson, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the ERYC profile page.
The generic ingredient in ERYC is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
The generic ingredient in ERYC is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
Summary for 050536
| Tradename: | ERYC |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | erythromycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050536
Suppliers and Packaging for NDA: 050536
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYC | erythromycin | CAPSULE, DELAYED REL PELLETS;ORAL | 050536 | NDA AUTHORIZED GENERIC | Mayne Pharma Inc. | 68308-250 | 68308-250-10 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68308-250-10) |
| ERYC | erythromycin | CAPSULE, DELAYED REL PELLETS;ORAL | 050536 | NDA AUTHORIZED GENERIC | Dr. Reddy's Labratories Inc. | 75907-076 | 75907-076-01 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (75907-076-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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