Details for New Drug Application (NDA): 065436
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The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 065436
Tradename: | MINOCYCLINE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | minocycline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065436
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 065436 | ANDA | Dr. Reddy's Laboratories Limited | 55111-637 | 55111-637-01 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-637-01) |
MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 065436 | ANDA | Dr. Reddy's Laboratories Limited | 55111-637 | 55111-637-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (55111-637-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Dec 26, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Dec 26, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Dec 26, 2007 | TE: | AB | RLD: | No |
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