Details for New Drug Application (NDA): 063067
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The generic ingredient in DYNACIN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 063067
Tradename: | DYNACIN |
Applicant: | Alvogen |
Ingredient: | minocycline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 063067
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DYNACIN | minocycline hydrochloride | CAPSULE;ORAL | 063067 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-5262 | 68071-5262-3 | 30 CAPSULE in 1 BOTTLE (68071-5262-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jul 31, 1990 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Sep 15, 1999 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Aug 14, 1990 | TE: | RLD: | No |
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