An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075111
Company: ACTAVIS MID ATLANTIC

Products on ANDA 075111

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.02%	SOLUTION;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075111

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium%20Bromide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75111ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
04/03/2001	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/17/2000	SUPPL-6	Labeling		Label is not available on this site.
08/17/2000	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/17/2000	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/23/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/23/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/23/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 075111

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-111_Ipratropium%20Bromide_prntlbl.pdf

Top