Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215082
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/08/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/06/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
LINCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 300MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LINCOCIN | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050317 | PFIZER |
LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212770 | ARTHUR GRP |
LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215657 | GLAND PHARMA LTD |
LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215082 | MICRO LABS |
LINCOMYCIN HYDROCHLORIDE | LINCOMYCIN HYDROCHLORIDE | EQ 300MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201746 | XGEN PHARMS |