Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012015
Company: OAK PHARMS AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COGENTIN BENZTROPINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription AP Yes 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
12/21/1959 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
02/03/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/26/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/22/2013 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf
04/22/2013 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf
07/27/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/2001 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf
04/15/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/26/1996 SUPPL-21 Labeling

Label is not available on this site.

10/31/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/14/1986 SUPPL-18 Labeling

Label is not available on this site.

11/02/1981 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/19/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/14/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1979 SUPPL-13 Labeling

Label is not available on this site.

05/05/1977 SUPPL-11 Labeling

Label is not available on this site.

01/15/1975 SUPPL-9 Labeling

Label is not available on this site.

07/01/1974 SUPPL-6 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/22/2013 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf
04/22/2013 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf

COGENTIN

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 090233 FRESENIUS KABI USA
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 090287 HIKMA FARMACEUTICA
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 091525 NAVINTA LLC
COGENTIN BENZTROPINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 012015 OAK PHARMS AKORN

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