FDA.reportPublic FDA data

Application 217078

Type
ANDA
Sponsor
PRECISION DOSE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEINJECTABLE;INJECTIONEQ 100MG BASE/VIALNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217078-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217078-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217078-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217078-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217078-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217078-001AP1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217078-001AP1a50c72e98297…

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 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-07-09Warnings, Adverse reactionsName fallback
brand name: doxycycline hyclate
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
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEChartwell RX, LLCfad03768-f1d2-459f-965e-0ec29f189f1f2026-06-30Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limited2deeee4f-b342-a178-e063-6394a90af8972026-06-26Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE HYCLATE
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limitedb8b76aaa-575b-497f-b854-c42bc992c7842026-06-26Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE HYCLATE
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESt. Mary's Medical Park Pharmacy02f87c60-8425-1a1e-e063-6294a90a0c942026-06-25Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE HYCLATE
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATESlate Run Pharmaceuticals, LLCf31e69fc-e513-40e4-91b5-22ccf1ed94372026-06-23Warnings, Adverse reactionsName fallback
brand name: doxycycline hyclate
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
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.c96d3986-9d92-4ec4-a319-a50aeb2f4fe72026-06-12Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.e24a3292-0d4f-4692-8cf7-a82bd19e59322026-06-08Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.5f523294-e62b-4da5-8799-047d4bed966f2026-06-04Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATESun Pharmaceutical Industries, Inc.214a9cfe-a522-4022-81d4-e59f447401fe2026-06-03Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE