Details for New Drug Application (NDA): 060641
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NDA 060641 describes RONDOMYCIN, which is a drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional details are available on the RONDOMYCIN profile page.
The generic ingredient in RONDOMYCIN is methacycline hydrochloride. There are six drug master file entries for this compound. Additional details are available on the methacycline hydrochloride profile page.
The generic ingredient in RONDOMYCIN is methacycline hydrochloride. There are six drug master file entries for this compound. Additional details are available on the methacycline hydrochloride profile page.
Summary for 060641
| Tradename: | RONDOMYCIN |
| Applicant: | Medpointe Pharm Hlc |
| Ingredient: | methacycline hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 060641
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 140MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 280MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | EQ 70MG BASE/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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