Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060582
Company: MONARCH PHARMS
Company: MONARCH PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEOSPORIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/03/1968 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/060582_original_approval_package.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/13/2006 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/23/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/27/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
NEOSPORIN
SOLUTION/DROPS;OPHTHALMIC; 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 064047 | BAUSCH AND LOMB |
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 065187 | NORDIC PHARMA |
NEOSPORIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 060582 | MONARCH PHARMS |