Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018238
Company: NESHER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICRO-K POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
MICRO-K 10 POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes 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
10/17/1980 ORIG-1 Approval Type 3 - New Dosage Form 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
04/30/2018 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018238s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018238Orig1s046ltr.pdf
03/09/2016 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/26/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/12/2014 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/25/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/20/2003 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18238slr031ltr.pdf
05/08/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/10/2000 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/13/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/19/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/12/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/30/1998 SUPPL-23 Labeling

Label is not available on this site.

01/30/1998 SUPPL-22 Labeling

Label is not available on this site.

06/30/1988 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1987 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/25/1985 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/08/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1985 SUPPL-13 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018238_s013_MICROK.pdf
03/16/1984 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/14/1984 SUPPL-11 Efficacy Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018238_s011_MICRO-K.pdf
05/04/1983 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1983 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1982 SUPPL-7 Unspecified

Label is not available on this site.

03/03/1982 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/03/1982 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/08/1982 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/17/1982 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/02/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1981 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2018 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018238s046lbl.pdf

MICRO-K

CAPSULE, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLOR-CON POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203106 UPSHER SMITH LABS
MICRO-K POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018238 NESHER PHARMS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 077419 ACTAVIS LABS FL INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208864 ADARE PHARMS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202886 ANCHEN PHARMS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204210 LANNETT CO INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203002 LUPIN LTD
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204828 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200185 PADDOCK LLC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205549 PII
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201944 TRIS PHARMA INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208445 ZYDUS PHARMS

MICRO-K 10

CAPSULE, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLOR-CON POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203106 UPSHER SMITH LABS
MICRO-K 10 POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018238 NESHER PHARMS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 077419 ACTAVIS LABS FL INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208864 ADARE PHARMS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202128 AMNEAL PHARMS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202886 ANCHEN PHARMS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202868 GLENMARK PHARMS LTD
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204210 LANNETT CO INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203002 LUPIN LTD
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204828 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200185 PADDOCK LLC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205549 PII
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201944 TRIS PHARMA INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208445 ZYDUS PHARMS

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