Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018553
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDERAL LA PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
INDERAL LA PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
INDERAL LA PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
INDERAL LA PROPRANOLOL HYDROCHLORIDE 60MG 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
04/19/1983 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
12/21/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/22/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/17/2011 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018553s037ltr.pdf
10/31/2007 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s036ltr.pdf
02/21/2007 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s035ltr.pdf
01/03/2007 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s034ltr.pdf
06/09/2004 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18553slr030ltr.pdf
02/06/2002 SUPPL-29 Labeling

Label is not available on this site.

03/31/2000 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/22/1999 SUPPL-27 Labeling

Label is not available on this site.

11/07/1997 SUPPL-26 Labeling

Label is not available on this site.

04/17/1990 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1990 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/10/1989 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/05/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1989 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1988 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/20/1987 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1986 SUPPL-15 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s015_INDERAL LA.pdf
03/18/1987 SUPPL-13 Efficacy-New Dosing Regimen Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s013_INDERAL LA.pdf
03/04/1986 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s012_INDERAL LA.pdf
11/20/1985 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/07/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1985 SUPPL-8 Efficacy

Label is not available on this site.

03/21/1985 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s006_INDERAL LA.pdf
08/09/1984 SUPPL-5 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s005_INDERAL LA.pdf
10/11/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/09/1984 SUPPL-1 Efficacy

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf

INDERAL LA

CAPSULE, EXTENDED RELEASE;ORAL; 160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDERAL LA PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 018553 ANI PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078494 ACTAVIS ELIZABETH
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078703 ADARE PHARMS INC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078065 NORTEC DEV ASSOC
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090321 ZYDUS PHARMS USA INC

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