Details for New Drug Application (NDA): 090422
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The generic ingredient in MINOCYCLINE HYDROCHLORIDE 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 090422
Tradename: | MINOCYCLINE HYDROCHLORIDE |
Applicant: | Sandoz |
Ingredient: | minocycline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090422
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090422 | ANDA | Sandoz Inc | 0781-5385 | 0781-5385-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5385-01) |
MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090422 | ANDA | Sandoz Inc | 0781-5385 | 0781-5385-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5385-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 45MG BASE | ||||
Approval Date: | Aug 13, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 90MG BASE | ||||
Approval Date: | Aug 13, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 135MG BASE | ||||
Approval Date: | Aug 13, 2009 | TE: | AB | RLD: | No |
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