Drugs@FDA application timeline

NDA012122

31 dated FDA-coded AP submissions from 1960-11-14 through 1998-06-26, connected to 30 source-defined action assignments and 0 official document links.

31Dated AP submissions
30Action assignments
0Official documents
0Exact enforcement reports
1Reviewed profile mappings

Reviewed identity mapping

Connected peptide profiles

Newest first

Submission and document chronology

31 submissions

1998-06-26 · status AP

Supplement 43

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1998-01-08 · status AP

Supplement 41

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1997-09-23 · status AP

Supplement 42

FDA action labels
Manufacturing (CMC)

No eligible official document row was listed for this submission in the retained archive.

1997-05-12 · status AP

Supplement 39

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1997-04-18 · status AP

Supplement 40

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1996-12-13 · status AP

Supplement 37

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1996-11-07 · status AP

Supplement 38

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1996-04-19 · status AP

Supplement 35

FDA action labels
Manufacturing (CMC)

No eligible official document row was listed for this submission in the retained archive.

1995-12-15 · status AP

Supplement 36

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1993-04-28 · status AP

Supplement 34

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1991-11-19 · status AP

Supplement 33

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1991-04-03 · status AP

Supplement 26

FDA action labels
Manufacturing (CMC)

No eligible official document row was listed for this submission in the retained archive.

1990-10-11 · status AP

Supplement 31

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1990-10-04 · status AP

Supplement 30

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1990-10-01 · status AP

Supplement 32

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1988-12-02 · status AP

Supplement 29

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1988-09-30 · status AP

Supplement 28

FDA action labels
Manufacturing (CMC)-Packaging

No eligible official document row was listed for this submission in the retained archive.

1988-01-05 · status AP

Supplement 27

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1986-09-30 · status AP

Supplement 25

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1984-12-13 · status AP

Supplement 19

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1984-08-09 · status AP

Supplement 18

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1984-08-02 · status AP

Supplement 17

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1983-07-21 · status AP

Supplement 16

FDA action labels
Labeling

No eligible official document row was listed for this submission in the retained archive.

1981-10-09 · status AP

Supplement 15

FDA action labels
Manufacturing (CMC)

No eligible official document row was listed for this submission in the retained archive.

1981-06-15 · status AP

Supplement 14

FDA action labels
Efficacy

No eligible official document row was listed for this submission in the retained archive.

1980-02-21 · status AP

Supplement 13

FDA action labels
Efficacy

No eligible official document row was listed for this submission in the retained archive.

1979-11-27 · status AP

Supplement 12

FDA action labels
Efficacy

No eligible official document row was listed for this submission in the retained archive.

1975-12-31 · status AP

Supplement 10

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1975-05-20 · status AP

Supplement 8

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1975-01-27 · status AP

Supplement 9

FDA action labels
Manufacturing (CMC)-Control

No eligible official document row was listed for this submission in the retained archive.

1960-11-14 · status AP

Original submission 1

No source action-type assignment was retained for this submission.

No eligible official document row was listed for this submission in the retained archive.

Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.