Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087242
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION Prescription AP 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
10/26/1983 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/31/1996 SUPPL-13 Labeling

Label is not available on this site.

12/22/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/28/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/05/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/05/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/05/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/05/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/01/1995 SUPPL-5 Labeling

Label is not available on this site.

05/07/1990 SUPPL-4 Labeling

Label is not available on this site.

04/09/1991 SUPPL-3 Labeling

Label is not available on this site.

12/27/1989 SUPPL-2 Labeling

Label is not available on this site.

AMINOPHYLLINE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION Prescription No AP 087242 HOSPIRA
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION Prescription No AP 087600 LUITPOLD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English