Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017439
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 125MG/ML INJECTABLE;INJECTION Discontinued None No No
HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE;INJECTION Discontinued None No 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
12/26/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/19/1999 SUPPL-124 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1998 SUPPL-123 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1997 SUPPL-122 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1991 SUPPL-120 Labeling

Label is not available on this site.

05/14/1991 SUPPL-119 Labeling

Label is not available on this site.

05/14/1991 SUPPL-118 Labeling

Label is not available on this site.

06/12/1989 SUPPL-117 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1990 SUPPL-116 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/14/1988 SUPPL-115 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1988 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

05/14/1991 SUPPL-113 Labeling

Label is not available on this site.

05/12/1986 SUPPL-112 Manufacturing (CMC)

Label is not available on this site.

03/27/1985 SUPPL-111 Labeling

Label is not available on this site.

03/23/1981 SUPPL-109 Efficacy

Label is not available on this site.

03/23/1981 SUPPL-108 Efficacy

Label is not available on this site.

03/23/1981 SUPPL-107 Efficacy

Label is not available on this site.

03/23/1981 SUPPL-106 Efficacy

Label is not available on this site.

03/23/1981 SUPPL-105 Efficacy

Label is not available on this site.

03/23/1981 SUPPL-104 Efficacy

Label is not available on this site.

03/23/1981 SUPPL-102 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-101 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-100 Labeling

Label is not available on this site.

03/23/1981 SUPPL-99 Labeling

Label is not available on this site.

01/23/1980 SUPPL-98 Labeling

Label is not available on this site.

01/23/1980 SUPPL-97 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-96 Labeling

Label is not available on this site.

01/23/1980 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1980 SUPPL-92 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-91 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-89 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-84 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-82 Efficacy

Label is not available on this site.

01/23/1980 SUPPL-80 Labeling

Label is not available on this site.

01/23/1980 SUPPL-79 Labeling

Label is not available on this site.

01/23/1980 SUPPL-78 Labeling

Label is not available on this site.

01/23/1980 SUPPL-76 Labeling

Label is not available on this site.

01/23/1980 SUPPL-74 Labeling

Label is not available on this site.

01/23/1980 SUPPL-73 Labeling

Label is not available on this site.

01/23/1980 SUPPL-72 Labeling

Label is not available on this site.

01/23/1980 SUPPL-71 Labeling

Label is not available on this site.

01/23/1980 SUPPL-70 Labeling

Label is not available on this site.

01/23/1980 SUPPL-69 Labeling

Label is not available on this site.

01/23/1980 SUPPL-68 Labeling

Label is not available on this site.

01/23/1980 SUPPL-67 Labeling

Label is not available on this site.

12/07/1977 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1980 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1977 SUPPL-16 Labeling

Label is not available on this site.

07/20/1976 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/03/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1976 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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