FDA.reportPublic FDA data

Application 205115

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 75MG BASENoNo
003DOXYCYCLINEDOXYCYCLINECAPSULE;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
A205115-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18
A205115-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18
A205115-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A205115-001AB
A205115-002AB
A205115-003AB

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 22:54:322026-06A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18a50c72e98297…
2026-08-01 22:54:322026-06A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18a50c72e98297…
2026-08-01 22:54:322026-06A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205115-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205115-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205115-003AB1a50c72e98297…

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.7028b7f9-21cd-4c8e-97aa-a3e7d849939b2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.dedebcb4-3c3f-4487-a488-36af12640c922026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 61919-624
doxycyclineDOXYCYCLINEA-S Medication Solutions2c7795c9-9e4e-477a-ad9f-01e4c55c06b62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 50090-4833
doxycyclineDOXYCYCLINEAvPAKa5b28a41-db12-af7c-e053-2995a90ace092026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 50268-280
ndc (product): 50268-281
doxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.fef9580d-8850-4cbb-89eb-2b4d40ee59c92025-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 68382-706
ndc (product): 68382-707
ndc (product): 68382-782
doxycyclineDOXYCYCLINEZydus Lifesciences Limitedaa01035d-8b4a-4fdc-bfdf-2b39df0d8fc92024-11-28Exact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 65841-821
ndc (product): 65841-822
ndc (product): 65841-823
doxycyclineDOXYCYCLINEBryant Ranch Prepack5f989cc1-48ae-41bb-b297-2f8c83760b6d2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 71335-1479
doxycyclineDOXYCYCLINEProficient Rx LPf3ba6c30-ada3-4a57-9ff8-30558202b9aa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (product): 63187-712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4833doxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-4833doxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-4833doxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-4833doxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50268-280doxycyclinedoxycyclineAvPAKANDACurrent
50268-280doxycyclinedoxycyclineAvPAKANDACurrent
50268-280doxycyclinedoxycyclineAvPAKANDACurrent
50268-281doxycyclinedoxycyclineAvPAKANDACurrent
50268-281doxycyclinedoxycyclineAvPAKANDACurrent
50268-281doxycyclinedoxycyclineAvPAKANDACurrent
55700-723doxycyclinedoxycyclineQuality Care Products, LLCANDACurrent
55700-723doxycyclinedoxycyclineQuality Care Products, LLCANDACurrent
55700-723doxycyclinedoxycyclineQuality Care Products, LLCANDACurrent
61919-624DOXYCYCLINE MONOHYDRATEDOXYCYCLINE MONOHYDRATEDIRECT RXANDACurrent
61919-624DOXYCYCLINE MONOHYDRATEDOXYCYCLINE MONOHYDRATEDIRECT RXANDACurrent
61919-624DOXYCYCLINE MONOHYDRATEDOXYCYCLINE MONOHYDRATEDIRECT RXANDACurrent
63187-712doxycyclinedoxycyclineProficient Rx LPANDACurrent
63187-712doxycyclinedoxycyclineProficient Rx LPANDACurrent
65841-821doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-821doxycyclinedoxycyclineZydus Lifesciences LimitedANDACurrent
65841-821doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-821doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-822doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-822doxycyclinedoxycyclineZydus Lifesciences LimitedANDACurrent
65841-822doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-822doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-823doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-823doxycyclinedoxycyclineZydus Lifesciences LimitedANDACurrent
65841-823doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
65841-823doxycyclinedoxycyclineCadila Healthcare LimitedANDACurrent
67296-1385doxycyclinedoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1385doxycyclinedoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1385doxycyclinedoxycyclineRedPharm Drug, Inc.ANDACurrent
68382-706doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-706doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-706doxycyclinedoxycyclineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-706doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-707doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-707doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-707doxycyclinedoxycyclineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-707doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-782doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-782doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-782doxycyclinedoxycyclineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-782doxycyclinedoxycyclineZydus Pharmaceuticals (USA) Inc.ANDACurrent
71335-0436doxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
71335-0436doxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
71335-0436doxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
71335-1479doxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
71335-1479doxycyclinedoxycyclineBryant Ranch PrepackANDACurrent