Application 020720

Type
NDA
Sponsor
PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REZULINTROGLITAZONETABLET;ORAL200MGNoNo
002REZULINTROGLITAZONETABLET;ORAL400MGNoNo
003REZULINTROGLITAZONETABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020720-001REZULINTROGLITAZONE200MGTABLET / ORAL1997-01-29
N020720-002REZULINTROGLITAZONE400MGTABLET / ORAL1997-01-29
N020720-003REZULINTROGLITAZONE300MGTABLET / ORAL1997-08-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020720-001REZULIN200MGTABLET / ORAL1997-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020720-002REZULIN400MGTABLET / ORAL1997-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020720-003REZULIN300MGTABLET / ORAL1997-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020720-001REZULIN200MGTABLET / ORAL1997-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020720-002REZULIN400MGTABLET / ORAL1997-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020720-003REZULIN300MGTABLET / ORAL1997-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020720-001REZULIN200MGTABLET / ORAL1997-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020720-002REZULIN400MGTABLET / ORAL1997-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020720-003REZULIN300MGTABLET / ORAL1997-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020720-001REZULIN200MGTABLET / ORAL1997-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020720-002REZULIN400MGTABLET / ORAL1997-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020720-003REZULIN300MGTABLET / ORAL1997-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020720-001REZULIN200MGTABLET / ORAL1997-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020720-002REZULIN400MGTABLET / ORAL1997-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020720-003REZULIN300MGTABLET / ORAL1997-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020720-001REZULIN200MGTABLET / ORAL1997-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020720-002REZULIN400MGTABLET / ORAL1997-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020720-003REZULIN300MGTABLET / ORAL1997-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020720-001REZULIN200MGTABLET / ORAL1997-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020720-002REZULIN400MGTABLET / ORAL1997-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020720-003REZULIN300MGTABLET / ORAL1997-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020720-001REZULIN200MGTABLET / ORAL1997-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020720-002REZULIN400MGTABLET / ORAL1997-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020720-003REZULIN300MGTABLET / ORAL1997-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020720-001REZULIN200MGTABLET / ORAL1997-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020720-002REZULIN400MGTABLET / ORAL1997-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020720-003REZULIN300MGTABLET / ORAL1997-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020720-001REZULIN200MGTABLET / ORAL1997-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020720-002REZULIN400MGTABLET / ORAL1997-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020720-003REZULIN300MGTABLET / ORAL1997-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020720-001REZULIN200MGTABLET / ORAL1997-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020720-002REZULIN400MGTABLET / ORAL1997-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020720-003REZULIN300MGTABLET / ORAL1997-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020720-001REZULIN200MGTABLET / ORAL1997-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020720-002REZULIN400MGTABLET / ORAL1997-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020720-003REZULIN300MGTABLET / ORAL1997-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020720-001REZULIN200MGTABLET / ORAL1997-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020720-002REZULIN400MGTABLET / ORAL1997-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020720-003REZULIN300MGTABLET / ORAL1997-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020720-001REZULIN200MGTABLET / ORAL1997-01-298072bd15b7f6…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41620SUPPL2003-06-17
41618SUPPL2003-06-17
41615SUPPL2003-06-17
20879SUPPL2003-06-17
41621SUPPL1999-06-16
35227SUPPL1999-06-16
25632SUPPL1999-06-16
25631SUPPL1999-06-16
20880SUPPL1999-06-16
13286SUPPL1999-06-16
41619SUPPL1997-08-14
41617SUPPL1997-08-14
41616SUPPL1997-08-04