Details for New Drug Application (NDA): 211975
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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 211975
Tradename: | ERYTHROMYCIN |
Applicant: | Torrent |
Ingredient: | erythromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211975
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 211975
Suppliers and Packaging for NDA: 211975
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | erythromycin | TABLET, DELAYED RELEASE;ORAL | 211975 | ANDA | Torrent Pharmaceuticals Limited | 13668-586 | 13668-586-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-01) |
ERYTHROMYCIN | erythromycin | TABLET, DELAYED RELEASE;ORAL | 211975 | ANDA | Torrent Pharmaceuticals Limited | 13668-586 | 13668-586-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 250MG | ||||
Approval Date: | Jul 26, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 26, 2021 | TE: | AB | RLD: | No |
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