Details for New Drug Application (NDA): 201746
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NDA 201746 describes LINCOMYCIN HYDROCHLORIDE, which is a drug marketed by Geneyork Pharms, Gland Pharma Ltd, Micro Labs, Slate Run Pharma, Watson Labs, and Xgen Pharms, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the LINCOMYCIN HYDROCHLORIDE profile page.
The generic ingredient in LINCOMYCIN HYDROCHLORIDE is lincomycin hydrochloride. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lincomycin hydrochloride profile page.
The generic ingredient in LINCOMYCIN HYDROCHLORIDE is lincomycin hydrochloride. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lincomycin hydrochloride profile page.
Summary for 201746
| Tradename: | LINCOMYCIN HYDROCHLORIDE |
| Applicant: | Xgen Pharms |
| Ingredient: | lincomycin hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 201746
Suppliers and Packaging for NDA: 201746
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LINCOMYCIN HYDROCHLORIDE | lincomycin hydrochloride | INJECTABLE;INJECTION | 201746 | ANDA | Henry Schein, Inc. | 0404-9901 | 0404-9901-10 | 1 VIAL in 1 BAG (0404-9901-10) / 10 mL in 1 VIAL |
| LINCOMYCIN HYDROCHLORIDE | lincomycin hydrochloride | INJECTABLE;INJECTION | 201746 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0350 | 39822-0350-2 | 10 VIAL in 1 CARTON (39822-0350-2) / 2 mL in 1 VIAL (39822-0350-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 300MG BASE/ML | ||||
| Approval Date: | Jun 4, 2015 | TE: | AP | RLD: | No | ||||
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