FDA.reportPublic FDA data

Application 065377

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINETABLET;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINETABLET;ORALEQ 75MG BASENoNo
003DOXYCYCLINEDOXYCYCLINETABLET;ORALEQ 100MG BASENoNo

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
A065377-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORAL2006-11-07
A065377-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORAL2006-11-07
A065377-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORAL2006-11-07

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
2026-08-01 22:54:322026-06A065377-001DOXYCYCLINEEQ 50MG BASETABLET / ORAL2006-11-07a50c72e98297…
2026-08-01 22:54:322026-06A065377-002DOXYCYCLINEEQ 75MG BASETABLET / ORAL2006-11-07a50c72e98297…
2026-08-01 22:54:322026-06A065377-003DOXYCYCLINEEQ 100MG BASETABLET / ORAL2006-11-07a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 103 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.bcc95094-80ed-4023-b2a6-955a4810bfbe2026-07-30Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEWellhouse Pharma, LLC57f97f68-11fb-4900-9efb-ca3b00818d8e2026-07-24Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.fa2d9328-b688-47af-8c4d-dc328cf353922026-06-24Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINE HYCLATEAcella Pharmaceuticals, LLC3fb9f5ad-90a2-4858-bc34-f800d8b2fa902026-06-19Warnings, Adverse reactionsName fallback
brand name: Doxycycline
DoxycyclineDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.c96d3986-9d92-4ec4-a319-a50aeb2f4fe72026-06-12Warnings, Adverse reactionsName fallback
brand name: Doxycycline
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEA-S Medication Solutions55873d3e-09c4-4726-acfe-5da5815895752026-05-22Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEREMEDYREPACK INC.d3c0b756-30ba-4ef9-a178-fd785d7203732026-05-20Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEREMEDYREPACK INC.f0fbf63a-e75c-40cf-b2e9-429deaac899d2026-05-06Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEST. MARY'S MEDICAL PARK PHARMACY00b2aa98-dea2-90c3-e063-6294a90a35d62026-05-01Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.7f882f1a-fe75-4592-9df5-f0e4bf1d232e2026-04-08Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEMeitheal Pharmaceuticals Inc.7772e702-20b3-473a-8bd5-9c7c92e753c62026-04-07Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.7028b7f9-21cd-4c8e-97aa-a3e7d849939b2026-03-27Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.dedebcb4-3c3f-4487-a488-36af12640c922026-03-25Warnings, Adverse reactionsName fallback
brand name: doxycycline
generic name: DOXYCYCLINE
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEProficient Rx LPd9388b32-dcb8-4dff-8a35-8fccb31bd1f82026-03-01Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsName fallback
brand name: Doxycycline
generic name: DOXYCYCLINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6021DoxycyclineDoxycyclineMylan Pharmaceuticals IncANDACurrent
0378-6022DoxycyclineDoxycyclineMylan Pharmaceuticals IncANDACurrent
0378-6023DoxycyclineDoxycyclineMylan Pharmaceuticals IncANDACurrent
0378-6023DoxycyclineDoxycyclineMylan Pharmaceuticals Inc.ANDACurrent