Application 050007

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIBRAMYCINDOXYCYCLINE HYCLATECAPSULE;ORALEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002VIBRAMYCINDOXYCYCLINE HYCLATECAPSULE;ORALEQ 100MG BASEYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050007-001VIBRAMYCINDOXYCYCLINE HYCLATEEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N050007-002VIBRAMYCINDOXYCYCLINE HYCLATEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050007-001VIBRAMYCINEQ 50MG BASECAPSULE / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050007-001VIBRAMYCINEQ 50MG BASECAPSULE / ORALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORALRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050007-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050007-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050007-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050007-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050007-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050007-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050007-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050007-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050007-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050007-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050007-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050007-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050007-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050007-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050007-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050007-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050007-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050007-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050007-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050007-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050007-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050007-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050007-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050007-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050007-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050007-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050007-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050007-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050007-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050007-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050007-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050007-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050007-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050007-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050007-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050007-002AB1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.2c29f716-bdb0-437d-92a4-d856b87db9762026-08-06Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-08-05Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.c8194d6e-c407-465e-a342-4d2d9756dfc42026-08-04Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.db53637e-16ac-41b0-b9d5-553471405d642026-08-03Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-07-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.6e3d0691-c071-441c-9b00-22a3803050662026-07-03Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEChartwell RX, LLCfad03768-f1d2-459f-965e-0ec29f189f1f2026-06-30Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limited2deeee4f-b342-a178-e063-6394a90af8972026-06-26Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limitedb8b76aaa-575b-497f-b854-c42bc992c7842026-06-26Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESt. Mary's Medical Park Pharmacy02f87c60-8425-1a1e-e063-6294a90a0c942026-06-25Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATESlate Run Pharmaceuticals, LLCf31e69fc-e513-40e4-91b5-22ccf1ed94372026-06-23Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEAcella Pharmaceuticals, LLC3fb9f5ad-90a2-4858-bc34-f800d8b2fa902026-06-19Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div PNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
0069-0950Vibramycin Hyclatedoxycycline hyclatePfizer Laboratories Div Pfizer IncNDACurrent
59762-3690Doxycyclinedoxycycline hyclateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83083SUPPL 2025-08-12
83079SUPPL 2025-08-11
81845SUPPL 2025-04-08
81789SUPPL 2025-04-02
61437SUPPL2019-12-26
61412SUPPL2019-12-23
56669SUPPL2018-12-07
56625SUPPL2018-12-04
49111SUPPL2017-07-28
49092SUPPL2017-07-27
46589SUPPL2016-12-29
46503SUPPL2016-12-21
38908SUPPL2016-04-07
29975SUPPL2016-04-05
38907SUPPL2015-05-07
38906SUPPL2014-10-02
29974SUPPL2014-09-16
17794SUPPL2013-09-09
7687SUPPL2013-09-09
17793SUPPL2013-05-01
7686SUPPL2013-05-01
17792SUPPL2011-05-16
17791SUPPL2008-02-14
7685SUPPL2008-02-13
29973SUPPL2004-03-16
29972SUPPL2002-06-18